Pharmacovigilance Jobs in Chennai

Why This Role MattersPharmacovigilance is a critical function in the pharmaceutical and healthcare industry that focuses on monitoring, detecting, assessing, and preventing adverse drug reactions. Ensuring the safety of medicines after they reach the market is essential for protecting patients and maintaining trust in healthcare systems. Professionals working in pharmacovigilance contribute to global drug safety by identifying potential risks associated with medicines and ensuring that these risks are reported and managed according to international regulatory standards.In this role, the Pharmacovigilance Services Associate supports drug safety surveillance activities by managing safety case reports, reviewing adverse event information, and ensuring accurate documentation in global safety databases. The role also involves collaboration with regulatory teams and healthcare stakeholders to ensure compliance with pharmacovigilance guidelines. Working with a global professional services organization like Accenture provides exposure to international pharmacovigilance processes and opportunities to contribute to large-scale healthcare and pharmaceutical safety programs.Job DescriptionAccenture is hiring Pharmacovigilance Services Associates to support its Pharmacovigilance Operations and Drug Safety Surveillance team. This position focuses on identifying, reviewing, and processing adverse event reports in compliance with global pharmacovigilance regulations and client-specific standard operating procedures.The role requires professionals to manage Individual Case Safety Reports (ICSRs), monitor safety information received from multiple sources, and ensure accurate data entry and processing in global safety databases. The associate will also assist in evaluating adverse drug reactions, performing medical coding, and ensuring that safety reports are submitted within regulatory timelines.Candidates will work with cross-functional teams including regulatory affairs specialists, safety scientists, and pharmacovigilance experts. This role offers an excellent opportunity for life sciences graduates who want to build a long-term career in pharmacovigilance, drug safety, regulatory affairs, and pharmaceutical risk management.Key Features of the Role• Job Title: Pharmacovigilance Services Associate / Drug Safety Associate• Department: Pharmacovigilance Operations – Drug Safety Surveillance• Organization: Accenture• Experience Required: 1–3 years• Qualification: BAMS / Bachelor’s or Master’s Degree in Life Sciences• Industry: Pharmaceutical Safety & Healthcare Services• Work Environment: Global pharmacovigilance operations teamResponsibilitiesCase Intake and Case Creation• Identify and create safety cases in the global safety database from reports received via intake workflows, client mailboxes, electronic gateways, and other reporting sources.• Retrieve new incoming safety information and follow-up correspondence for existing safety cases.• Ensure that all safety cases are recorded accurately and processed according to client guidelines and regulatory requirements.Adverse Event Monitoring and Evaluation• Collect, evaluate, and document Adverse Events (AE), Serious Adverse Events (SAE), and Suspected Unexpected Serious Adverse Reactions (SUSAR).• Verify the validity of Individual Case Safety Reports and ensure that cases meet regulatory reporting criteria.• Perform duplicate checks and review case data to confirm medical significance and accuracy.Case Processing and Data Management• Conduct case triage, prioritization, and data entry for safety cases in the pharmacovigilance database.• Process ICSRs end-to-end according to regulatory deadlines, service-level agreements, and internal quality standards.• Ensure all safety case information is complete, accurate, and consistent across systems.Medical Coding and Documentation• Perform medical coding using internationally recognized dictionaries such as MedDRA and WHO Drug Dictionary.• Document clinical information, patient history, suspect drug information, and adverse reactions.• Prepare detailed safety narratives and maintain proper pharmacovigilance documentation.Regulatory Reporting and Compliance• Submit adverse event reports to global safety databases and regulatory authorities when required.• Monitor report submissions and troubleshoot issues related to safety data transmission.• Ensure that pharmacovigilance activities comply with international regulatory guidelines and company SOPs.Quality Assurance and Follow-Up• Review safety case data for completeness, accuracy, and regulatory compliance.• Identify missing information and request clarification from reporters or marketing companies when necessary.• Track follow-up actions and ensure resolution of pending safety case items.Operational Support and Collaboration• Work closely with pharmacovigilance teams, regulatory partners, and cross-functional departments.• Support pharmacovigilance audits, inspections, and compliance activities.• Assist in preparing pharmacovigilance meeting minutes, documentation, and safety report tracking.Required Qualifications• Bachelor’s Degree in Life Sciences or related discipline.• Bachelor of Ayurvedic Medicine and Surgery (BAMS) or Master’s Degree in Life Sciences.• Basic understanding of pharmacovigilance processes, adverse event reporting, and drug safety monitoring.Educational RequirementsCandidates must hold one of the following qualifications from a recognized institution:• Bachelor’s Degree in Life Sciences• Master’s Degree in Life Sciences• Bachelor of Ayurvedic Medicine and Surgery (BAMS)These academic backgrounds provide the scientific foundation needed to understand drug safety concepts, medical terminology, and pharmacovigilance workflows.Experience and SkillsExperience• 1–3 years of experience in pharmacovigilance operations or drug safety surveillance.• Experience in handling Individual Case Safety Reports and safety database systems is preferred.Technical Skills• Knowledge of pharmacovigilance safety databases and case processing workflows.• Familiarity with medical coding dictionaries such as MedDRA and WHO-Drug.• Proficiency in Microsoft Office tools for documentation and reporting.Professional Skills• Strong medical writing and documentation abilities.• Excellent English communication skills including reading, writing, listening, and speaking.• Ability to work efficiently in a fast-paced environment while maintaining accuracy.• Strong analytical thinking and attention to detail.• Commitment to regulatory compliance and quality standards.Salary InsightsPharmacovigilance professionals in India typically receive competitive salary packages depending on experience and technical expertise. Associates with one to three years of experience can expect industry-standard compensation along with opportunities for career development, training programs, and exposure to global pharmacovigilance operations.Company OverviewAccenture is a global professional services company known for its expertise in consulting, technology services, digital transformation, and business operations. With a presence in more than 120 countries, the organization supports clients across industries including healthcare, pharmaceuticals, finance, and technology.The company’s pharmacovigilance and healthcare operations teams help pharmaceutical organizations maintain drug safety compliance, manage regulatory reporting, and ensure patient safety worldwide. By combining advanced technology with human expertise, Accenture continues to deliver innovative solutions that improve healthcare systems and pharmaceutical safety programs.FAQsQ1. What does a Pharmacovigilance Services Associate do?A Pharmacovigilance Services Associate monitors adverse drug reaction reports, processes safety cases, and ensures compliance with pharmacovigilance regulations.Q2. What qualifications are required for this role?Candidates should have a Bachelor’s or Master’s degree in Life Sciences or a BAMS degree.Q3. What experience is required?The position typically requires one to three years of experience in pharmacovigilance or drug safety operations.Q4. What technical knowledge is useful for this role?Knowledge of pharmacovigilance databases, MedDRA coding, WHO Drug Dictionary, and safety case processing workflows is beneficial.Q5. What career growth opportunities are available in pharmacovigilance?Professionals can progress to roles such as Senior Pharmacovigilance Associate, Drug Safety Specialist, Safety Scientist, or Pharmacovigilance Manager.Application Tips• Highlight pharmacovigilance or drug safety experience clearly in your resume.• Mention knowledge of MedDRA coding, safety databases, and adverse event reporting.• Emphasize medical writing and documentation skills.• Demonstrate your ability to follow regulatory guidelines and pharmacovigilance SOPs.• Include examples of safety case processing, drug safety monitoring, or regulatory reporting tasks.

Why This Role MattersPharmacovigilance plays a crucial role in ensuring the safety and effectiveness of medicines after they are released into the market. Professionals working in drug safety surveillance help detect, assess, and prevent adverse drug reactions that could impact patient health. This role directly supports pharmaceutical companies and regulatory bodies in maintaining high safety standards for medicines used worldwide.A Pharmacovigilance Services Associate is responsible for identifying and evaluating adverse event reports, maintaining safety databases, and ensuring that all drug safety information is handled according to international regulatory guidelines. By processing safety cases accurately and within required timelines, pharmacovigilance professionals contribute significantly to protecting patients and strengthening trust in healthcare systems.Job DescriptionA global professional services organization, Accenture, is seeking Pharmacovigilance Services Associates to support its pharmacovigilance operations and drug safety surveillance activities. This role involves managing safety case data, reviewing adverse event reports, performing medical coding, and ensuring regulatory compliance across global pharmacovigilance systems.The position focuses on handling Individual Case Safety Reports (ICSRs) and ensuring accurate documentation, evaluation, and submission of adverse event information in the global safety database. The associate will work closely with cross-functional teams, regulatory stakeholders, and internal safety teams to maintain high-quality pharmacovigilance standards. This opportunity is ideal for life sciences graduates who are interested in building a career in pharmacovigilance, drug safety operations, regulatory compliance, and pharmaceutical risk management.Key Features of the Role• Job Title: Pharmacovigilance Services Associate / Drug Safety Associate• Department: Pharmacovigilance Operations – Drug Safety Surveillance• Organization: Accenture• Experience Required: 1–3 years• Qualification: BAMS / Bachelor’s or Master’s Degree in Life Sciences• Industry: Pharmaceutical Safety & Healthcare Services• Work Environment: Global pharmacovigilance operations teamResponsibilitiesCase Intake and Case Processing• Identify and create safety cases in the global safety database from reports received through intake workflows, client mailboxes, electronic gateways, and other reporting sources.• Retrieve new safety information and follow-up correspondence for existing cases while maintaining compliance with company SOPs and regulatory requirements.• Perform triage, prioritization, and case processing activities for both serious and non-serious safety cases.Adverse Event Monitoring• Collect, review, and evaluate Adverse Event (AE), Serious Adverse Event (SAE), and Suspected Unexpected Serious Adverse Reaction (SUSAR) reports.• Ensure timely processing and evaluation of safety cases according to global regulatory timelines and internal service level agreements.• Perform duplicate checks and confirm the validity of Individual Case Safety Reports.Medical Coding and Safety Documentation• Conduct medical and drug coding for safety cases using standardized dictionaries such as MedDRA and WHO Drug Dictionary.• Draft detailed case narratives and document relevant clinical information based on available source data.• Maintain complete and accurate pharmacovigilance documentation for regulatory and internal review purposes.Regulatory Compliance and Reporting• Ensure all pharmacovigilance activities are performed according to regulatory requirements and company safety procedures.• Submit adverse event reports to global safety databases and regulatory authorities when required.• Monitor submissions and resolve issues related to report transmissions or database updates.Data Review and Quality Control• Review safety case data to ensure accuracy, completeness, and consistency across pharmacovigilance systems.• Validate safety data and correct discrepancies when necessary.• Monitor performance indicators and ensure that case processing meets defined quality standards and timelines.Operational Support and Collaboration• Coordinate with cross-functional teams, including regulatory affairs, clinical research, and safety operations teams.• Support audits, inspections, and compliance activities related to pharmacovigilance processes.• Assist with safety documentation, pharmacovigilance meeting minutes, and archival of safety records.Required Qualifications• Bachelor’s Degree in Life Sciences or related discipline.• Bachelor of Ayurvedic Medicine and Surgery (BAMS) or Master’s Degree in Life Sciences.• Basic knowledge of pharmacovigilance workflows and adverse event reporting processes.Educational RequirementsCandidates must hold one of the following qualifications from a recognized institution:• Bachelor’s Degree in Life Sciences• Master’s Degree in Life Sciences• Bachelor of Ayurvedic Medicine and Surgery (BAMS)These educational backgrounds provide the scientific and clinical knowledge required to understand adverse drug reactions, clinical terminology, and pharmacovigilance processes.Experience and SkillsExperience• 1–3 years of experience in pharmacovigilance operations or drug safety surveillance.• Experience handling Individual Case Safety Reports and safety database systems is preferred.Technical Skills• Familiarity with pharmacovigilance safety databases and case processing workflows.• Knowledge of medical coding dictionaries such as MedDRA and WHO-Drug.• Proficiency in Microsoft Office applications for documentation and reporting tasks.Professional Skills• Strong medical writing and documentation abilities.• Excellent communication skills in English (reading, writing, speaking, and listening).• Ability to work in a fast-paced environment and manage multiple safety cases simultaneously.• Strong attention to detail and analytical thinking.• Commitment to maintaining high standards of regulatory compliance.Salary InsightsPharmacovigilance professionals in India receive competitive compensation depending on experience, technical expertise, and role responsibilities. Entry-level associates with 1–3 years of experience can expect attractive salary packages along with opportunities for professional growth, training programs, and exposure to global pharmacovigilance operations.Company OverviewAccenture is one of the world’s leading professional services companies specializing in digital transformation, consulting, technology, and operations. The company operates in more than 120 countries and serves clients across multiple industries including healthcare, pharmaceuticals, finance, and technology.With a workforce of hundreds of thousands of professionals globally, Accenture combines advanced technology with human expertise to deliver innovative solutions. Its pharmacovigilance and healthcare operations teams support pharmaceutical companies in maintaining regulatory compliance, monitoring drug safety, and ensuring the protection of patient health worldwide.FAQsQ1. What does a Pharmacovigilance Services Associate do?A Pharmacovigilance Services Associate monitors and processes adverse drug reaction reports, maintains safety databases, and ensures compliance with global pharmacovigilance regulations.Q2. What qualifications are required for this position?Candidates should hold a Bachelor’s or Master’s degree in Life Sciences or a BAMS degree from a recognized institution.Q3. What experience is required for this role?The position typically requires 1–3 years of experience in pharmacovigilance, drug safety operations, or related pharmaceutical safety functions.Q4. What technical knowledge is important for this job?Knowledge of pharmacovigilance databases, MedDRA coding, WHO-Drug dictionaries, and safety reporting workflows is highly beneficial.Q5. What career growth opportunities exist in pharmacovigilance?Professionals can progress to roles such as Drug Safety Specialist, Senior Pharmacovigilance Associate, Safety Scientist, Pharmacovigilance Manager, or Regulatory Safety Expert.Application Tips• Highlight pharmacovigilance or drug safety experience clearly in your resume.• Mention knowledge of MedDRA coding, safety databases, or adverse event reporting.• Emphasize medical writing and documentation skills.• Demonstrate your ability to work with regulatory guidelines and compliance processes.• Include examples of safety case processing or pharmacovigilance project involvement.

Why This Role MattersPharmacovigilance professionals play a vital role in ensuring patient safety by monitoring, evaluating, and reporting adverse drug reactions. This role helps pharmaceutical companies and regulatory authorities maintain drug safety standards throughout a product’s lifecycle. By identifying adverse events, managing safety databases, and ensuring regulatory compliance, Pharmacovigilance Associates contribute significantly to protecting public health and improving medication safety worldwide.Job DescriptionA global professional services organization, Accenture, is hiring Pharmacovigilance Services Associates to support drug safety surveillance and case processing activities. The role involves managing Individual Case Safety Reports (ICSRs), reviewing adverse event data, performing medical coding, and ensuring compliance with international pharmacovigilance guidelines and regulatory timelines.This position is ideal for life science graduates who want to build a career in pharmacovigilance, drug safety monitoring, and regulatory compliance within the pharmaceutical and healthcare industry.Key Features of the Role• Job Title: Pharmacovigilance Services Associate / Pharmacovigilance Associate• Department: Pharmacovigilance Operations – Drug Safety Surveillance• Experience Required: 1–3 years• Qualification: BAMS / Bachelor’s or Master’s Degree in Life Sciences• Industry: Pharmaceutical Safety & Healthcare Services• Work Environment: Global pharmacovigilance operations team• Organization: AccentureResponsibilitiesCase Intake & Processing• Identify and create safety cases in the global safety database from multiple intake sources including client mailboxes, electronic gateways, and safety reporting systems.• Perform triage, prioritization, and data entry for serious and non-serious adverse event cases.• Process Individual Case Safety Reports (ICSRs) according to regulatory timelines and client SOPs.Adverse Event Monitoring• Collect, evaluate, and document adverse events (AEs), serious adverse events (SAEs), and suspected unexpected serious adverse reactions (SUSARs).• Perform duplicate checks and validate case authenticity in safety databases.• Assess seriousness, causality, and medical relevance of reported events.Medical Coding & Documentation• Perform medical coding using standardized dictionaries such as MedDRA and WHO Drug Dictionary.• Draft safety narratives for regulatory reporting and documentation.• Maintain accurate pharmacovigilance documentation and safety case records.Regulatory Compliance & Reporting• Ensure all pharmacovigilance activities comply with global regulatory requirements and company SOPs.• Submit safety reports to global safety databases and regulatory authorities.• Track regulatory submissions and troubleshoot submission-related issues.Data Management & Quality Assurance• Review safety data for accuracy, completeness, and consistency.• Monitor case processing quality metrics and ensure adherence to turnaround time (TAT) and KPIs.• Resolve pending action items, follow-ups, or clarifications related to safety cases.Collaboration & Operational Support• Coordinate with cross-functional teams, regulatory partners, and pharmacovigilance stakeholders.• Assist in pharmacovigilance audits, inspections, and compliance reviews.• Support pharmacovigilance projects, documentation archiving, and meeting coordination.Required Qualifications• Bachelor’s Degree in Life Sciences or equivalent.• Bachelor of Ayurvedic Medicine and Surgery (BAMS) or Master’s in Life Sciences.• Basic understanding of pharmacovigilance principles and drug safety processes.Educational RequirementsCandidates must possess one of the following degrees from a recognized institution:• Bachelor’s Degree in Life Sciences• Master’s Degree in Life Sciences• Bachelor of Ayurvedic Medicine and Surgery (BAMS)These qualifications provide the scientific knowledge required to understand adverse drug reactions, clinical terminology, and drug safety monitoring processes.Experience and SkillsExperience• 1–3 years of experience in pharmacovigilance or drug safety operations.• Experience handling ICSRs and safety database case processing is preferred.Technical Skills• Knowledge of safety databases and pharmacovigilance workflows.• Familiarity with medical dictionaries such as MedDRA and WHO-Drug.• Proficiency in Microsoft Office tools for documentation and reporting.Core Skills• Strong medical writing and documentation skills.• Excellent English communication skills (reading, writing, speaking, listening).• Ability to work in a fast-paced regulatory environment.• Strong analytical and problem-solving abilities.• High attention to detail and commitment to regulatory compliance.Salary InsightsPharmacovigilance Associates in India typically receive competitive salary packages based on experience and technical expertise. Compensation may include performance incentives, career development opportunities, and exposure to global pharmacovigilance operations.Company OverviewAccenture is a leading global professional services company with expertise in digital transformation, technology, consulting, and operations. The organization employs hundreds of thousands of professionals across more than 120 countries and delivers solutions that combine advanced technology with human ingenuity. Its pharmacovigilance and healthcare operations teams support pharmaceutical companies worldwide in maintaining drug safety, regulatory compliance, and patient protection.FAQsQ1. What is the primary responsibility of a Pharmacovigilance Associate?The primary responsibility is to monitor and process adverse drug reaction reports and maintain accurate safety records in compliance with regulatory standards.Q2. What qualifications are required for this role?Candidates must have a Bachelor’s or Master’s degree in Life Sciences or a BAMS degree.Q3. What experience level is required?The role requires 1–3 years of relevant pharmacovigilance or drug safety experience.Q4. What technical knowledge is useful for this role?Knowledge of MedDRA coding, WHO-Drug dictionaries, and pharmacovigilance safety databases is highly beneficial.Q5. What career growth opportunities exist in pharmacovigilance?Professionals can progress to roles such as Senior Drug Safety Associate, Pharmacovigilance Specialist, Safety Scientist, or Pharmacovigilance Manager.Application Tips• Highlight pharmacovigilance or drug safety experience in your resume.• Mention familiarity with MedDRA coding and safety databases.• Emphasize medical writing and documentation skills.• Include examples of adverse event case processing or safety monitoring tasks.• Demonstrate attention to regulatory compliance and quality standards.

Why This Role MattersThe Pharmacovigilance Services Specialist plays a critical role in ensuring patient safety through effective drug safety surveillance and regulatory compliance. This position oversees pharmacovigilance service delivery, ensuring high-quality case processing, risk management, and regulatory reporting aligned with global standards.By managing operational teams, mitigating risks, and ensuring timely submission of Individual Case Safety Reports (ICSRs), the role directly contributes to maintaining public trust in medicines and ensuring compliance with international pharmacovigilance regulations.Job DescriptionAccenture is hiring a Pharmacovigilance Services Specialist to oversee service delivery in drug safety surveillance operations. The selected candidate will manage pharmacovigilance case processing activities, coordinate with client project leads, oversee team performance, and ensure compliance with global regulatory requirements. The role may involve rotational shifts and interaction with internal and client stakeholders.Key Features of the Role• Position: Pharmacovigilance Services Specialist• Skill Area: Pharmacovigilance & Drug Safety Surveillance• Experience Required: 7–11 years• Qualification: B.Pharm / M.Pharm• Industry: Pharmacovigilance / Life Sciences Operations• Work Requirement: May require rotational shiftsKey ResponsibilitiesService Delivery & Team Management• Oversee end-to-end pharmacovigilance service delivery• Mobilize and manage resources to meet client requirements• Monitor team performance and ensure high-quality outputs• Manage risks, issues, and escalations with client and internal stakeholdersCase Processing & Drug Safety Operations• Manage case identification, data entry, and MedDRA coding• Oversee case processing, submissions, and follow-ups for ICSRs• Ensure compliance with global regulatory requirements and client guidelines• Maintain data accuracy in safety databasesRisk & Compliance Oversight• Support detection, assessment, and prevention of adverse drug effects• Ensure adherence to pharmacovigilance regulatory standards• Drive quality improvements and process optimization• Support compliance audits and regulatory inspectionsProblem Solving & Decision Making• Analyze and resolve moderately complex issues• Adapt existing methods to create improved solutions• Make decisions that impact team operations and service quality• Align team activities with strategic goals set by senior managementRequired QualificationsEducational Background:• Bachelor of Pharmacy (B.Pharm)• Master of Pharmacy (M.Pharm)Experience:• 7–11 years of experience in Pharmacovigilance / Drug Safety• Strong experience in ICSR case processing and regulatory submissions• Experience managing small teams or leading workstreamsCore Skills:• Strong analytical and problem-solving skills• Excellent written and verbal communication• Risk management and issue resolution capability• Collaboration and stakeholder management skills• Understanding of global pharmacovigilance regulationsSoft Skills:• Leadership and team coordination• Ability to work under deadlines• Client-facing communication skills• Adaptability in a dynamic environmentCompany OverviewAccenture is a global professional services organization with expertise in digital, cloud, security, strategy, consulting, technology, and operations. With over 784,000 employees serving clients in more than 120 countries, Accenture combines technology and human ingenuity to drive business transformation across industries. In the life sciences sector, Accenture supports pharmacovigilance services that ensure regulatory compliance, operational excellence, and patient safety.FAQsQ1. Is team management experience required?Yes, candidates should have experience managing small teams or workstreams.Q2. Is hands-on case processing experience necessary?Yes, strong exposure to ICSR case processing and MedDRA coding is required.Q3. Does the role involve client interaction?Yes, collaboration with client project leads and internal stakeholders is a key component.Q4. Are rotational shifts mandatory?Yes, this role may require working in rotational shifts.Q5. What experience level is expected?Candidates must have 7–11 years of pharmacovigilance experience.Application Tip• Highlight experience in ICSR case management and MedDRA coding• Showcase leadership or team management exposure• Mention regulatory submission and compliance experience• Demonstrate risk management and escalation handling examples• Include client-facing project coordination experience

Why This Role Matters• The role of Pharmacovigilance Services Specialist ensures the safety and efficacy of medications through the monitoring and analysis of data from clinical trials, healthcare providers, and patients.• You will be instrumental in the detection, assessment, and prevention of adverse effects related to pharmaceutical products, impacting patient health and public trust in medications.Job Description• As a Pharmacovigilance Services Specialist, you will work within Accenture’s Life Sciences R&D vertical, spanning services across research labs, clinical trials, regulatory services, pharmacovigilance, and patient services solutions.• You will collaborate with biopharma companies to improve patient outcomes and ensure compliance with regulatory requirements.Key Features of the Role:• Full-time, on-site role based in Greater Chennai Area• Involves working on pharmacovigilance and patient services solutions• Key responsibilities include analyzing and reporting on adverse effects from clinical trials, healthcare providers, and patients• Ensures adherence to regulatory compliance and fosters public trust in medicationsResponsibilities• Analyze and solve moderately complex problems• Create new solutions leveraging existing methods and procedures• Understand and implement the strategic direction set by senior management• Collaborate with peers, clients, and Accenture management teams• Lead small teams or contribute as an individual contributor within AccentureRequired Qualifications• MBBSEducational Requirements:• Medical Degree (MBBS)Experience and Skills:• 0 to 4 years of experience in the relevant field• Ability to work in a team, adaptable, and flexible• Quick learning abilities and agility in new tasksAge Eligibility:• No specific age criteria mentionedSalary Insights• Competitive salary (not disclosed)Company Overview• Accenture is a global professional services company combining experience and specialized skills across digital, cloud, and security.• With 784,000+ employees in 120+ countries, Accenture offers services in Strategy & Consulting, Technology & Operations, and Accenture Song.• Accenture strives to create value and success for clients, employees, and communities by embracing the power of change.FAQs1 Is prior experience in pharmacovigilance required? No, this role is open to those with up to 4 years of experience.2 Does the role involve shift work? Yes, this role may require you to work in rotational shifts.Application Tips• Tailor your resume to highlight relevant experience and qualifications.• Emphasize your teamwork, adaptability, and quick learning abilities.

Why This Role MattersPatient safety is the foundation of clinical research and pharmaceutical development. Pharmacovigilance ensures that adverse events are properly monitored, assessed, and reported in compliance with global regulatory standards. Effective safety oversight not only protects patients participating in clinical trials but also safeguards public health after products reach the market.The Supervisor – Pharmacovigilance role at ICON plc is central to maintaining high standards of drug safety reporting and regulatory compliance. This position directly influences the accuracy, timeliness, and integrity of adverse event reporting while leading a team responsible for critical safety operations.For professionals with strong pharmacovigilance experience and leadership capabilities, this role offers the opportunity to contribute to global clinical development programs within a world-leading healthcare intelligence and clinical research organization.Job DescriptionICON plc is seeking a Supervisor – Pharmacovigilance to join its dynamic and diverse team. The selected candidate will oversee day-to-day pharmacovigilance operations related to clinical trials and marketed products. The role involves supervising safety reporting processes, ensuring regulatory compliance, managing submission workflows, and guiding the pharmacovigilance team to maintain best-in-class reporting standards.The Supervisor will collaborate with cross-functional departments including clinical operations, regulatory affairs, and quality teams to optimize safety reporting systems and maintain compliance with global pharmacovigilance regulations. This position requires strong technical knowledge, leadership skills, and the ability to manage multiple safety workflows simultaneously.Key Features of the RoleLeadership opportunity within global pharmacovigilance operations.Exposure to clinical trial and post-marketing safety reporting.Direct interaction with regulatory authorities and global compliance frameworks.Collaboration with cross-functional global teams.Career progression within a leading clinical research organization.Responsibilities RequiredSupervise day-to-day pharmacovigilance safety reporting operations, ensuring timely and accurate submission of adverse event reports to regulatory authorities.Oversee safety case processing, medical review coordination, and submission tracking in accordance with global regulatory timelines.Ensure compliance with international pharmacovigilance regulations, guidelines, and internal standard operating procedures (SOPs).Manage safety submissions workflow and ensure proper documentation, quality checks, and audit readiness.Collaborate with clinical operations, regulatory affairs, and quality assurance teams to streamline safety reporting processes.Provide leadership, mentoring, and training to pharmacovigilance team members to ensure adherence to best practices.Monitor performance metrics and implement process improvements to enhance reporting efficiency and compliance.Support regulatory inspections and audits by preparing required documentation and addressing safety-related queries.Ensure accurate maintenance of safety databases and tracking systems.Identify potential compliance risks and implement corrective and preventive actions (CAPA) where required.Maintain high standards of data accuracy, confidentiality, and regulatory integrity across all pharmacovigilance activities.QualificationsThe ideal candidate will possess a strong academic background in life sciences or pharmacy, combined with practical pharmacovigilance and leadership experience.Educational Requirements:Bachelor’s degree in Life Sciences, Pharmacy, or a related field.Experience and Skills:Solid experience in pharmacovigilance or drug safety, particularly in clinical trials and/or post-marketing surveillance.Strong knowledge of global pharmacovigilance regulations and reporting guidelines (e.g., ICH, FDA, EMA frameworks).Experience supervising or mentoring pharmacovigilance team members.Strong understanding of safety database systems and submission workflows.Excellent communication and organizational skills.Ability to manage multiple priorities and ensure compliance with strict regulatory timelines.High attention to detail and commitment to data accuracy.Ability to work effectively in a cross-functional and global team environment.Salary InsightsCompensation will be competitive and aligned with global CRO industry standards for supervisory-level pharmacovigilance professionals. The overall package may include performance-based incentives and country-specific benefits aligned with experience and role responsibility.Additional benefits may include:Competitive salary structureHealth insurance options for employees and familiesRetirement planning benefitsLife assurance coverageGlobal Employee Assistance Programme (LifeWorks)Flexible, country-specific optional benefits such as childcare vouchers, gym memberships, and travel subsidiesGenerous annual leave entitlementsCompany OverviewICON plc is a world-leading healthcare intelligence and clinical research organization dedicated to advancing clinical development and improving patient outcomes. The company operates globally, supporting pharmaceutical, biotechnology, and medical device clients in delivering high-quality clinical research solutions.ICON fosters a culture of inclusion, innovation, and excellence, providing professionals with opportunities to grow within a diverse and performance-driven environment. The organization is committed to maintaining a workplace free from discrimination and promoting equal opportunity for all employees.FAQsIs supervisory experience mandatory for this role?Yes, prior experience in leading or mentoring pharmacovigilance teams is highly preferred.Does this role focus only on clinical trials?The role covers both clinical trial safety reporting and post-marketing surveillance activities.What regulatory knowledge is required?Strong knowledge of global pharmacovigilance regulations such as ICH guidelines and regulatory authority requirements (e.g., FDA, EMA).Are cross-functional collaborations involved?Yes, the role requires close coordination with clinical operations, regulatory affairs, and quality teams.What is the primary objective of the role?To ensure accurate, timely, and compliant safety reporting while leading pharmacovigilance operations effectively.Application TipsHighlight your pharmacovigilance experience, especially supervisory or leadership responsibilities.Mention regulatory frameworks and safety databases you have worked with.Provide examples of managing submission timelines and regulatory compliance.Demonstrate experience handling audits or inspections related to safety reporting.Be prepared to discuss real-world pharmacovigilance workflow management scenarios during the interview.

Roles & Responsibilities• Identify and create safety cases in global safety databases• Perform triage, case prioritization, and processing of AEs, SAEs, and SUSARs• Conduct medical coding using MedDRA and WHO-Drug Dictionary (WHODD)• Perform data entry and narrative writing in global safety systems• Assess seriousness and causality as per client SOPs• Submit safety reports within defined regulatory timelines• Conduct duplicate checks and validation of case data• Follow up for missing or incomplete safety information• Handle E2B submissions and regulatory reporting requirements• Translate source documents and case narratives where required• Participate in audits and regulatory inspections• Perform mailbox reconciliation and safety data tracking• Ensure strict adherence to global pharmacovigilance regulations and compliance frameworksQualification• B.Pharm (Bachelor of Pharmacy)• BSc Nursing• Bachelor’s Degree in Life SciencesExperience• 0–1 year of experience in Pharmacovigilance or Drug Safety (Freshers can apply)• Basic understanding of global safety reporting requirementsSkills• Knowledge of Pharmacovigilance and Drug Safety processes• Familiarity with safety databases and case processing workflows• Understanding of MedDRA and WHO-Drug coding• Proficiency in MS Office applications• Strong English communication and medical writing skills• High attention to detail and accuracy• Ability to meet strict timelines and quality KPIsAbout the OrganizationAccenture is a global professional services company specializing in digital, technology, and operations solutions. With a strong presence in life sciences and healthcare, Accenture supports global pharmaceutical companies through pharmacovigilance operations, regulatory compliance, and drug safety surveillance services.

Roles & Responsibilities• Lead safety submission activities for complex pharmacovigilance projects• Prepare and submit safety reports including PSURs and ICSRs in compliance with global regulatory standards• Oversee safety submission projects ensuring timelines, scope, and quality standards are met• Conduct detailed data analysis to identify safety trends and assess product risk profiles• Collaborate with cross-functional teams for timely adverse event reporting• Ensure compliance with global pharmacovigilance regulations and internal SOPs• Provide training and guidance to team members on PV reporting processes• Maintain inspection readiness and high-quality documentation standardsQualification• Bachelor’s degree in Life Sciences / Pharmacy or related field• Advanced degree preferredExperience• Minimum 6 years of experience in pharmacovigilance reporting within clinical/pharmaceutical environment• Strong safety submission experience (PSURs, ICSRs)• Minimum 1 year of project management experience including financial and scope oversightSkills• Strong analytical and data interpretation skills• Proficiency in safety databases and reporting tools• In-depth knowledge of global PV regulations and reporting requirements• Excellent communication and stakeholder management skills• Strong quality focus and compliance orientation• Ability to manage multiple projects in a matrix environmentAbout the OrganizationICON plc is a global healthcare intelligence and clinical research organization dedicated to advancing clinical development and improving patient outcomes. The company fosters an inclusive culture, innovation-driven environment, and offers competitive global benefits focused on employee well-being and professional growth.

Roles & Responsibilities• Oversee operation, administration, and maintenance of the Veeva Vault Safety system• Configure and customize Veeva Vault Safety to meet organizational and regulatory requirements• Implement and manage workflows for adverse event reporting, risk management, and safety data analysis• Ensure system compliance with global pharmacovigilance regulations (FDA, EMA, ICH, GVP)• Prepare and support submission of periodic safety reports and regulatory deliverables• Monitor regulatory updates and implement required system or process changes• Manage collection, processing, and analysis of safety data• Develop and generate safety reports for internal and external stakeholders• Ensure integrity, security, and confidentiality of pharmacovigilance data• Collaborate with clinical, regulatory, and IT teams to optimize system usage across drug development processes• Participate in cross-functional discussions on safety data trends and potential risks• Contribute to continuous improvement of pharmacovigilance systems and processesQualification• Bachelor’s or Master’s degree in Pharmacy, Nursing, Life Sciences, or a related disciplineExperience• 3–10 years of experience in Pharmacovigilance and Drug Safety• Hands-on experience with Veeva Vault Safety or similar safety database systemsSkills• Strong knowledge of global PV regulations and safety reporting requirements• Expertise in Veeva Vault Safety configuration, workflows, and data management• Excellent analytical and problem-solving skills• Proficiency in safety data analysis and reporting• Strong communication, collaboration, and stakeholder management skills• Ability to work independently as well as in a cross-functional team environmentAbout the OrganizationCognizant is a leading global professional services company helping clients transform their business, operating, and technology models for the digital era. With a strong focus on innovation, inclusion, and career growth, Cognizant supports organizations worldwide through industry-driven and technology-led solutions.

Role & Responsibilities • End-to-end ICSR processing • Safety case follow-up and submissions • Adhere to client and global regulatory guidelines • Conduct internal quality checks and documentation Qualification: B.Pharm / Life SciencesExperience: 1-3 years Skills • Knowledge of ICSR processing and safety case management • Familiarity with regulatory guidelines in Pharmacovigilance • Attention to detail and strong organizational skills • Ability to work in a compliance-driven, fast-paced environment About The Company • Accenture is a global leader in life sciences operations, focusing on regulatory services and pharmacovigilance. The company offers structured growth opportunities in the life sciences sector. Accenture fosters a diverse and inclusive work environment while collaborating with leading biopharma clients.

Role & Responsibilities • ICSR case intake and data entry • MedDRA coding and safety database management • Case processing and regulatory submissions • Compliance with global PV regulations (ICH, GVP)Qualification: B.Pharm / Life SciencesExperience: 0-1 year (Freshers eligible) Skills • Knowledge of Pharmacovigilance operations • Familiarity with MedDRA coding and safety databases • Attention to detail and compliance-driven mindset • Ability to work in rotational shifts About The Company • Accenture offers structured learning and growth opportunities in pharmacovigilance. • The company specializes in life sciences regulatory services and has a strong global presence. • Accenture works with leading biopharma clients and promotes an inclusive work culture.

Roles & Responsibilities: • Perform end-to-end pharmacovigilance case processing for clinical trial safety cases • Collect, assess, process, and submit adverse event (AE) and serious adverse event (SAE) reports • Ensure timely and accurate data entry in LSMV (LifeSphere MultiVigilance) database • Maintain compliance with global pharmacovigilance regulations (ICH-GCP, GVP, FDA, EMA) • Support signal detection activities and risk management assessments • Collaborate with cross-functional teams on safety queries and investigations • Stay updated with current drug safety guidelines and industry standards Qualification: • Bachelor’s degree in Life Sciences, Pharmacy, or related discipline Experience: • Minimum 2+ years of experience in pharmacovigilance case processing • Hands-on experience in Clinical Trial Safety Cases OR LSMV / Argus / Safety Databases Skills: • Strong analytical skills with high attention to detail • Excellent written and verbal communication skills • Proven commitment to quality, compliance, and patient safety About the Organisation: ICON plc is a global leader in healthcare intelligence and clinical research, dedicated to advancing patient safety and delivering high-quality clinical development solutions across the pharmaceutical and biotech industries.

Roles & Responsibilities • Perform end-to-end ICSR case processing for marketed products as per global regulations. • Assess seriousness, expectedness and causality and ensure timely global reporting. • Process literature ICSRs and maintain compliance with monitoring requirements. • Support aggregate reporting activities including PSURs and DSURs. • Maintain safety database integrity with hands-on experience in LSMV preferred. • Perform reconciliation activities and support KPI and SLA tracking. • Collaborate with medical, clinical and cross-functional teams on safety evaluations. • Support signal detection, risk management activities and identification of safety trends. • Participate in regulatory audits and inspections. • Train and mentor junior pharmacovigilance associates. • Review SOPs and contribute to continuous process improvement. Qualification • B.Pharm / M.Pharm, Pharm.D, BDS, B.Sc Nursing / M.Sc Nursing, BAMS / BHMS Experience • Minimum 4+ years of pharmacovigilance case processing experience. • Mandatory experience in Post-Marketing Surveillance (PMS). Skills • Strong knowledge of global pharmacovigilance regulations. • Hands-on experience with safety databases (LSMV preferred). • Expertise in ICSR processing for marketed products. • Experience with PSUR / DSUR and aggregate reports. • Familiarity with SDEA concepts and SLA / KPI management. • Audit and inspection readiness. • Excellent analytical, communication and documentation skills. • Proficiency in Microsoft Office tools. About the Company ICON plc is a global healthcare intelligence and clinical research organization delivering outsourced development and commercialization services to the pharmaceutical, biotechnology and medical device industries, supporting innovation and patient safety across the product lifecycle worldwide.

Role & Responsibilities • Perform end-to-end ICSR case processing for marketed products in compliance with global regulations • Assess seriousness, expectedness, causality, and ensure accurate global reporting • Process literature ICSRs and maintain monitoring compliance • Support aggregate reporting activities including PSURs and DSURs • Maintain pharmacovigilance database integrity (LSMV experience preferred) • Conduct reconciliation activities and support KPI/SLA tracking • Collaborate with medical, clinical, and cross-functional teams on safety evaluations • Identify safety trends and support signal detection and risk management • Participate in regulatory audits and inspections • Train and mentor junior pharmacovigilance associates • Review SOPs and contribute to continuous PV process improvement Qualification • B.Pharm / M.Pharm / Pharm.D / BDS / B.Sc Nursing / M.Sc Nursing / BAMS / BHMS Experience • 4+ years of pharmacovigilance case processing experience • Experience in Post-Marketing Surveillance (PMS) • Strong knowledge of global pharmacovigilance regulations • Hands-on experience with safety databases (LSMV preferred) • Familiarity with SDEA concepts and SLA/KPI management Skills • Pharmacovigilance & Drug Safety Operations • ICSR Processing (Marketed Products) • Aggregate Reports (PSUR / DSUR) • Global Safety Reporting • Signal Detection (supporting role) • Audit & Inspection Readiness • Excellent analytical and communication skills • Proficiency in Microsoft OfficeBenefits • Competitive salary & performance-based rewards • Multiple annual leave entitlements • Comprehensive health insurance for employee & family • Retirement & long-term savings plans • Global Employee Assistance Program (TELUS Health) – 24/7 support • Life assurance coverage • Flexible benefits (childcare support, gym discounts, travel subsidies, wellness programs) • Inclusive, diverse, and harassment-free workplace About The Company • ICON Plc – A global leader in healthcare intelligence and clinical research, ICON provides comprehensive solutions across the clinical trial process. With a strong commitment to regulatory compliance and patient safety, ICON offers career advancement opportunities for professionals in pharmacovigilance and drug safety.