Pharmacovigilance Jobs in Bangalore

Why This Role MattersPharmacovigilance is a critical function in the pharmaceutical and healthcare industry, ensuring patient safety through continuous monitoring of adverse events and compliance with global drug safety regulations. A Drug Safety Associate plays an essential role in maintaining regulatory timelines, processing safety data, and supporting global reporting obligations.This position is ideal for Life Sciences and Pharmacy graduates who want to build a long-term career in pharmacovigilance, regulatory affairs, or drug safety operations. It provides structured exposure to ICSR processing, safety submissions, regulatory intelligence, literature surveillance, and affiliate support activities. Working in a regulated safety environment helps professionals develop strong analytical thinking, documentation accuracy, and compliance discipline—core skills required in global clinical safety operations.Job DescriptionThe Drug Safety Associate will support global pharmacovigilance operations, including Individual Case Safety Report (ICSR) processing, safety submissions, literature monitoring, regulatory support, and affiliate coordination. The role requires adherence to global regulations, client-specific workflows, and internal Standard Operating Procedures (SOPs).The position involves monitoring safety data sources, ensuring accurate data capture in safety databases, maintaining compliance metrics, and supporting regulatory reporting activities. Associates are expected to follow structured workflows, maintain documentation integrity, and escalate issues appropriately.Key Features of the Role:• Exposure to global pharmacovigilance systems• Hands-on ICSR case processing experience• Involvement in regulatory submissions and compliance tracking• Opportunity to work with international health authorities• Learning and development through structured training modules• Participation in audits and inspections• Strong career pathway into senior safety and regulatory rolesResponsibilitiesGeneral Responsibilities• Develop knowledge of safety profiles, labeling, and global regulations• Follow project-specific workflows and procedures• Support compliance with regulatory reporting timelines• Assist in audit and inspection preparation• Review basic safety metrics and escalate issues• Maintain documentation and archiving standards• Participate in LMS training modules and complete assigned coursework• Ensure accurate and timely timesheet submissionICSR Processing• Monitor incoming safety reports from mailboxes, EudraVigilance, and literature sources• Perform literature searches and valid case data entry into safety databases• Triage incoming reports for completeness and validity• Request translations where required• Ensure medical cohesiveness and document consistency• Prepare ADR forms and coversheets• Perform MedDRA coding as per standard guidance• Conduct follow-up and query management• Prepare medically accurate case narratives• Perform quality and validation checks• Support compliance activities and late case investigations• Generate compliance metrics and support reconciliation activities• Perform database updates such as product additions or deletionsSafety Submissions• Submit ICSRs and periodic safety reports to regulatory authorities and ethics committees• Maintain reporting schedules and ensure timely submissions• Perform unblinding for safety reporting when required• Support development of global safety reporting procedures• Register products and organizations for electronic submissions• Track submission compliance and reporting quality• Prepare documentation within EDMS/eTMF systems• Participate in audits and inspections• Coach junior associates when applicableLiterature Search and Review• Develop and maintain search strategies based on client requirements• Screen scientific literature for potential ADRs and safety signals• Perform peer review of literature abstracts• Identify and forward safety signals for medical review• Maintain local journal lists and update search strategies• Insert full-text articles into databases where required• Coordinate with internal and external stakeholders to resolve search-related issuesAffiliate Services• Support communication between global safety teams and local affiliates• Maintain product information systems• Assist with translation and literature monitoring• Support local health authority interactions• Participate in reconciliation activities• Coordinate country-specific literature screeningRegulatory Support and Intelligence• Manage regulatory applications and lifecycle changes• Support global submissions including eCTD registrations and renewals• Track safety reports such as RMP, PBRER, and PASS• Maintain regulatory intelligence databases and trackers• Review country-specific safety reporting requirements• Collaborate with global pharmacovigilance intelligence teams• Ensure compliance with Service Level Agreements and KPIsRequired QualificationsCandidates must demonstrate foundational knowledge of pharmacovigilance processes and regulatory frameworks. Strong attention to detail, analytical ability, and documentation accuracy are essential. The role requires comfort working with structured databases and adherence to compliance-driven workflows.Educational Requirements:• Degree in Life Sciences, Health Sciences, or Biomedical Sciences• Pharmacy, Microbiology, Biochemistry, Biotechnology, or related disciplines preferred• Equivalent relevant qualification or work experience may be consideredExperience and Skills:• Foundational knowledge of drug safety regulations• Basic understanding of healthcare terminology• Familiarity with ICH guidelines and regional requirements (preferred)• Introductory exposure to pharmacovigilance databases• Basic proficiency in MS Office applications• Good communication and organizational skills• Strong willingness to learn and grow in drug safety operationsSalary InsightsCompensation is aligned with entry-level to junior pharmacovigilance roles in the healthcare industry. Salary may vary depending on experience, region, and organizational banding structure. Employees typically receive structured training, compliance exposure, and long-term growth opportunities within drug safety and regulatory domains.Company OverviewThe hiring organization operates within global pharmacovigilance and regulatory compliance frameworks, supporting sponsors and healthcare clients worldwide. The company maintains strict adherence to international drug safety standards, regulatory timelines, and quality benchmarks. Employees benefit from structured learning environments, exposure to global safety operations, and professional growth within clinical safety and regulatory affairs functions.FAQsIs prior pharmacovigilance experience mandatory?No, related healthcare experience is advantageous but not mandatory.What databases are commonly used in this role?Safety databases for ICSR processing and regulatory submission portals.Is this role suitable for fresh graduates?Yes, candidates with foundational knowledge and strong learning intent can apply.Does the role involve regulatory submissions?Yes, safety submissions to health authorities are a core responsibility.What career growth can be expected?Progression into Senior Drug Safety Associate, Safety Reporting Specialist, Regulatory Specialist, or PV Quality roles.Application Tips• Revise ICH-GCP and pharmacovigilance basics• Understand ICSR workflow and MedDRA coding fundamentals• Highlight internship or safety database exposure• Demonstrate attention to detail during interviews• Emphasize willingness to learn global safety regulations

Why This Role MattersThis Clinical Safety / Pharmacovigilance position offers a unique opportunity to contribute to patient safety and the lifecycle management of pharmaceutical products. You will play a critical role in monitoring, evaluating, and reporting adverse events (AEs) from clinical trials and post-marketing activities. By ensuring accurate and timely safety reporting, you directly support regulatory compliance, safeguard patient health, and help maintain the integrity of clinical studies and marketed products. This role is ideal for individuals looking to grow in the pharmacovigilance or clinical safety field, gain hands-on regulatory experience, and contribute to a global healthcare impact.Job DescriptionFortrea is seeking a detail-oriented Clinical Safety Specialist to join our growing team. The successful candidate will manage and process expedited adverse events (AEs/SAEs), maintain safety databases, support regulatory submissions, and provide high-quality service to clients and internal teams. You will work closely with Clinical Operations, Data Management, and Regulatory teams to ensure compliance with national and international standards, including ICH-GCP, Good Clinical Practice, and global pharmacovigilance requirements.This role requires a proactive individual capable of handling multiple safety cases while maintaining strict accuracy and regulatory compliance. You will assist with signal detection, safety reporting, quality review, and documentation management, contributing to the overall success of clinical trials and post-marketing safety programs.Key Features of the Role• Exposure to global pharmacovigilance and clinical safety operations• Hands-on experience with AE/SAE reporting, safety database management, and regulatory submissions• Work across multiple therapeutic areas and client projects• Opportunity to participate in signal detection and safety trend analysis• Mentorship and career growth within an international CRO environment• Involvement in audits, inspections, and CAPA implementation• Collaborative cross-functional team environment• Opportunity to support both clinical trial and post-marketing safety projectsResponsibilities• Manage receipt and processing of all adverse event reports, whether spontaneous or from clinical trials• Enter safety data into AE databases and tracking systems accurately• Review adverse events for completeness, accuracy, and expedited reporting readiness• Write patient narratives and code events using MedDRA• Determine listedness against product labels for marketed products• Identify clinically significant missing information and ensure follow-up• Submit expedited AE/SAE reports to clients, regulatory authorities, ethics committees, and investigators within study-specified timelines• Perform database reconciliation with Data Management or sponsors as required• Maintain adverse event tracking systems and ensure all project files are up to date• Assist with the reporting of Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs)• Participate in signal detection, trend analysis, and pattern recognition activities• Support preparation of Annual IND reports, PSURs, and DSURs• Prepare and maintain study safety files for archiving at project completion• Support audits, inspections, and quality assurance initiatives• Assist with CAPA development and implementation for safety-related findings• Mentor and train junior safety staff in AE processing and pharmacovigilance procedures• Maintain up-to-date knowledge of Standard Operating Procedures (SOPs), Work Instructions (WIs), and regulatory guidelinesRequired Qualifications• PharmD, MS/MA, BS/BA, or Associate degree in Pharmacy, Biological Sciences, Nursing, Life Sciences, or related field• Relevant experience in safety/pharmacovigilance or CRO/biotech/pharmaceutical industry• Experience with AE/SAE processing, safety databases, narratives, queries, and regulatory submissions• Knowledge of ICH Guidelines and worldwide regulatory requirements• Ability to work independently with minimal supervision• Excellent written and verbal communication skillsEducational Requirements• BS/BA, PharmD, or equivalent degree in a health sciences, medical, pharmacy, or life sciences discipline• Non-degree candidates with 2+ years of clinical safety experience may be considered• Postgraduate education or relevant certifications in pharmacovigilance or clinical research preferredExperience and Skills• Minimum 1–2 years of experience in pharmacovigilance, clinical safety, or related area• High attention to detail and accuracy in handling sensitive clinical data• Strong organisational skills with the ability to manage multiple tasks simultaneously• Proficient in Microsoft Office (Word, Excel, Outlook) and database systems• Team player with the ability to liaise with clients, investigators, and regulatory personnel• Understanding of GCP, pharmacovigilance processes, and regulatory safety requirements• Ability to review cumulative safety data for submissions to regulatory authorities or DSMBsSalary Insights• Competitive industry-aligned remuneration based on experience and qualifications• Opportunities for bonuses or career progression within the pharmacovigilance team• Additional benefits include professional training, mentorship, and potential travel opportunities (~5%)Company OverviewFortrea is a global Contract Research Organisation (CRO) committed to delivering high-quality clinical research and pharmacovigilance services. We support pharmaceutical, biotech, and medical device companies by providing end-to-end clinical trial solutions and safety monitoring services. Our team collaborates with clients, regulatory authorities, and clinical research teams worldwide, ensuring the highest standards of patient safety and compliance.Our culture is collaborative, professional, and supportive, with opportunities for career growth, continuous learning, and exposure to international regulatory and safety practices.FAQsQ: What type of safety experience is required?A: Experience with AE/SAE processing, writing narratives, database entry, regulatory submissions, and pharmacovigilance procedures is required.Q: Is travel required?A: Minimal travel (~5%) may be required for audits or project-related visits, including overnight stays.Q: Do I need prior clinical trial experience?A: Prior clinical trial experience is highly desirable but not mandatory if you have relevant pharmacovigilance or safety experience.Q: What training is provided?A: Fortrea provides comprehensive training in safety databases, regulatory processes, AE/SAE reporting, and SOP compliance.Q: Can non-degree holders apply?A: Yes, candidates with extensive safety experience (2+ years) will be considered.Application Tips• Ensure your CV highlights relevant safety, pharmacovigilance, or clinical trial experience• Include examples of AE/SAE processing, regulatory submissions, or quality/compliance work• Mention any experience with safety databases, MedDRA coding, or PSUR/DSUR reporting• Highlight your ability to work independently and manage competing priorities• Include any relevant certifications, training, or postgraduate qualifications in clinical safety• Demonstrate communication, attention to detail, and teamwork skills

Why This Role MattersIn global drug development, patient safety is the highest priority. Regulatory authorities require strict adherence to expedited safety reporting timelines to ensure that emerging safety signals are identified and addressed promptly. The Safety Submission Specialist plays a mission-critical role in ensuring that Individual Case Safety Reports (ICSRs) are accurately reviewed, documented, and submitted within mandated timelines.This role directly supports compliance with global pharmacovigilance regulations established by authorities such as the U.S. Food and Drug Administration, the European Medicines Agency, and guidelines from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Failure to comply with safety reporting obligations can result in regulatory findings, inspection observations, or significant reputational and financial risk.By ensuring accurate submission of expedited reports, maintaining compliance metrics, and monitoring regulatory updates, the Safety Submission Specialist contributes directly to safeguarding patients and maintaining the integrity of clinical trials and post-marketing programs.Job DescriptionThe Safety Submission Specialist is responsible for reviewing, preparing, and transmitting required ICSRs in both electronic and paper formats to global regulatory agencies, business partners, affiliates, and other designated recipients. Working with minimal supervision, this role ensures adherence to local and international pharmacovigilance requirements.The position requires strong operational expertise in safety databases, regulatory portals, compliance tracking systems, and documentation management processes. In addition to submission responsibilities, the specialist supports reconciliation activities, deviation management, regulatory intelligence monitoring, and compliance metric reporting.This role demands accuracy, attention to detail, regulatory awareness, and the ability to work effectively in a deadline-driven environment.Key Features of the Role• Direct involvement in global ICSR submission processes• Exposure to both clinical trial and post-marketing pharmacovigilance programs• Responsibility for compliance metrics and deviation management• Interaction with international regulatory reporting portals• Cross-functional collaboration with safety, regulatory, and clinical teamsEssential Responsibilities• Review and transmit expedited ICSRs to global regulatory agencies and partners.• Monitor the Drug Safety Inbox for submission acknowledgements and confirmations.• Maintain submission trackers, distribution logs, and compliance spreadsheets.• Generate regulatory reports such as CIOMS I, MedWatch 3500A, and XML files from the global safety database.• Prepare and distribute Investigator Safety Letters and final submission documentation.• Perform case closure and ensure electronic filing of SAE documentation.• Initiate and manage expedited reporting deviations, including investigations, extension requests, and CAPAs.• Conduct SAE reconciliation activities and issue queries as required.• Reconcile and send SUSAR Gap Packs in accordance with reporting timelines.• Maintain and update expedited reporting distribution lists.• Track and reconcile compliance metrics to ensure adherence to submission timelines.• Support generation of distribution and submission compliance reports.• Monitor regulatory intelligence databases for updates to global reporting requirements.• Provide country-specific reporting insights to support Safety Reporting Plan development.• Ensure documentation is filed in the Trial Master File (TMF) according to SOPs and sponsor requirements.• Support updates to the Pharmacovigilance System Master File (PSMF) for post-marketing programs.• Maintain compliance with SOPs, Work Instructions, GCP, ICH guidelines, GVP, and global drug/device regulations.• Participate in department meetings and continuous training activities.Required Qualifications• Minimum 2 years of experience in clinical trial drug safety within a Pharma or CRO environment.• Demonstrated understanding of global safety reporting regulations and pharmacovigilance guidelines.• Experience with ARGUS Safety Database.• Hands-on experience with regulatory reporting portals including EMA EudraVigilance and UK MHRA systems.• Bachelor’s degree (BA/BS preferred) in Life Sciences, Pharmacy, or related discipline.Educational Requirements• Bachelor’s degree in Pharmacy, Life Sciences, Biotechnology, or related scientific field.• Additional training or certification in pharmacovigilance is advantageous.Experience and Skills• Strong working knowledge of global pharmacovigilance regulations, including FDA and EU requirements.• Practical experience preparing and submitting expedited safety reports.• Familiarity with EudraVigilance and MHRA reporting frameworks.• Ability to generate regulatory forms such as CIOMS I and MedWatch 3500A.• Proficiency in safety databases (ARGUS preferred).• Excellent documentation and tracking skills.• Strong analytical and problem-solving capabilities.• Ability to manage strict timelines and multiple priorities.• High attention to detail and compliance-focused mindset.• Effective communication and cross-functional collaboration skills.Salary InsightsCompensation for this role is competitive within the Indian pharmacovigilance and CRO market. Salary structure may depend on:• Years of safety reporting experience• Regulatory portal expertise• Technical proficiency in ARGUS and compliance systems• Exposure to global pharmacovigilance programsIn addition to base salary, employees may receive performance incentives, health benefits, paid leave, and other company-sponsored programs aligned with regional standards.Company OverviewThis position is part of the Clinical Solutions Business Unit under Precision for Medicine, a global organization specializing in clinical research, biomarker-driven development, and regulatory support services. The division focuses on delivering high-quality clinical trial management and pharmacovigilance services to pharmaceutical and biotechnology partners.The organization emphasizes ethical conduct, regulatory excellence, and patient-centric research practices. Employees benefit from a structured environment that supports professional growth, compliance excellence, and international exposure.FAQsWhat is the primary focus of this role?Reviewing and submitting expedited ICSRs to global regulatory authorities while maintaining compliance with pharmacovigilance regulations.Is experience with ARGUS mandatory?Yes, working knowledge of the ARGUS Safety Database is required.Which regulatory systems should candidates be familiar with?Experience with EMA EudraVigilance, UK MHRA, and other recognized reporting portals is required.Does this role include deviation management?Yes, the specialist handles expedited reporting deviations, investigations, and CAPAs.Is this role specific to clinical trials only?The role supports both clinical trial programs and post-marketing pharmacovigilance activities.Application Tips• Highlight direct experience with expedited ICSR submissions.• Emphasize knowledge of global pharmacovigilance regulations and reporting timelines.• Provide examples of compliance tracking and deviation management.• Mention hands-on experience with ARGUS and regulatory portals.• Demonstrate your ability to manage deadlines in a highly regulated environment.

Why This Role MattersIn clinical research and post-marketing surveillance, timely and accurate safety reporting is non-negotiable. Regulatory authorities worldwide require expedited reporting of serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSARs) to ensure patient safety and public health protection.The Safety Submission Specialist plays a critical operational role in maintaining regulatory compliance by reviewing, preparing, and transmitting Individual Case Safety Reports (ICSRs) to global regulatory agencies and partners. This position directly impacts regulatory credibility, sponsor trust, and patient protection.Errors or delays in safety reporting can result in regulatory findings, compliance risks, and potential harm to patients. This role ensures that safety submissions are accurate, complete, and aligned with global reporting standards established by authorities such as the U.S. Food and Drug Administration, the European Medicines Agency, and in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines.Job DescriptionThe Safety Submission Specialist is responsible for reviewing, preparing, tracking, and transmitting expedited safety reports (paper and electronic) to global regulatory authorities, business partners, affiliates, and other required destinations.Working with minimal supervision, this role ensures compliance with local and international pharmacovigilance regulations. The specialist maintains up-to-date knowledge of global reporting requirements and supports safety compliance metrics, reconciliation activities, and regulatory intelligence monitoring.This role requires technical proficiency in safety databases, regulatory submission platforms, and compliance tracking systems, as well as strong organizational and analytical skills.Key Features of the Role• Direct involvement in global ICSR submission processes• Regulatory interaction across multiple international regions• Exposure to clinical trial and post-marketing pharmacovigilance• Compliance and deviation management responsibilities• Cross-functional collaboration with safety, regulatory, and clinical teamsResponsibilities• Review and transmit expedited ICSRs (paper and electronic) to regulatory authorities and partners.• Monitor Drug Safety Inbox for submission acknowledgements and confirmation receipts.• Generate final clinical trial regulatory reports such as CIOMS I, MedWatch 3500A, and XML outputs from the global safety database.• Prepare and distribute Investigator Safety Letters and final submission documentation.• Maintain submission trackers and distribution spreadsheets for compliance monitoring.• Perform case closure and electronic filing of SAE documentation.• Initiate, investigate, and document expedited reporting deviations, including CAPAs and extension requests.• Conduct SAE reconciliation activities and raise queries when discrepancies are identified.• Reconcile and send SUSAR Gap Packs as required.• Maintain and update expedited reporting email distribution lists.• Track and reconcile compliance metrics for safety reporting timelines.• Support generation of overall submission compliance reports for internal review.• Monitor regulatory intelligence databases for updates in country-specific reporting requirements.• Contribute regulatory intelligence insights for development of Safety Reporting Plans.• Ensure documentation is filed in the Trial Master File (TMF) according to SOPs and sponsor requirements.• Support documentation updates for the Pharmacovigilance System Master File (PSMF) where applicable.• Maintain compliance with SOPs, Work Instructions, GCP, ICH guidelines, GVP requirements, and global drug/device regulations.• Participate in departmental meetings and ongoing training activities.Required Qualifications• Minimum 2 years of experience in clinical trial drug safety within Pharma or CRO environments.• Demonstrated knowledge of global pharmacovigilance regulations, including FDA, EU, and ICH requirements.• Working experience with ARGUS Safety Database.• Experience with reporting portals such as EMA EudraVigilance and UK MHRA systems.• Bachelor’s degree (BA/BS preferred) in Life Sciences, Pharmacy, or related field.Educational Requirements• Bachelor’s degree in Pharmacy, Life Sciences, Biotechnology, or related discipline.• Additional pharmacovigilance certifications are advantageous.Experience and Skills• Strong understanding of global safety reporting regulations.• Hands-on experience in ICSR preparation and expedited submissions.• Familiarity with EudraVigilance and UK MHRA reporting frameworks.• Experience generating regulatory reports (CIOMS I, MedWatch 3500A, XML).• Proficiency in safety databases such as ARGUS.• Strong attention to detail and compliance-driven mindset.• Analytical thinking with the ability to manage deviations and CAPAs.• Excellent documentation and tracking capabilities.• Ability to manage multiple deadlines in a fast-paced regulatory environment.• Strong communication skills for cross-functional coordination.Salary InsightsCompensation for a Safety Submission Specialist is competitive and aligned with pharmacovigilance industry standards. Salary packages typically depend on:• Years of pharmacovigilance experience• Exposure to global reporting portals• Technical expertise in safety databases• Experience handling regulatory deviations and compliance metricsAdditional benefits may include health insurance, retirement plans, paid leave, and employee wellness programs depending on company policy and region.Company OverviewThe organization operates within the pharmaceutical and clinical research domain, supporting global drug development and post-marketing safety programs. With a strong focus on regulatory compliance and patient safety, the company maintains rigorous quality systems and pharmacovigilance frameworks.Through adherence to international standards and proactive regulatory intelligence monitoring, the organization ensures that all safety reporting obligations are met accurately and within required timelines.FAQsWhat is the primary responsibility of a Safety Submission Specialist?The primary responsibility is reviewing and submitting expedited ICSRs to global regulatory authorities while ensuring compliance with reporting timelines.Is experience with ARGUS mandatory?Yes, working knowledge of ARGUS Safety Database is required for this role.What regulatory authorities should candidates be familiar with?Candidates should understand reporting requirements aligned with the U.S. FDA, European regulations, and ICH guidelines.Does the role involve deviation management?Yes, the specialist handles expedited reporting deviations, investigations, and CAPAs.Is experience with EudraVigilance required?Yes, familiarity with EMA EudraVigilance and UK MHRA reporting portals is essential.Application Tips• Highlight hands-on experience with ICSR submissions and safety databases.• Demonstrate knowledge of global pharmacovigilance regulations.• Provide examples of compliance tracking and deviation management.• Emphasize experience with regulatory portals such as EudraVigilance.• Showcase your ability to manage strict regulatory timelines without errors.

Roles & Responsibilities• Perform data entry of safety data into adverse event tracking systems• Write patient safety narratives and accurately code adverse events using MedDRA and WHODD (for marketed products, if applicable)• Assist in listedness assessment against appropriate product labels• Support causality assessment in collaboration with medical reviewers• Generate queries and collect missing or discrepant safety information• Assist in submission of expedited SAE/SUSAR reports to clients, regulatory authorities, ethics committees, investigators, vendors, and project teams within agreed timelines• Support preparation, review, and approval of Periodic Safety Reports (PSRs) for investigational products/devices as per applicable regulations• Ensure compliance with company and sponsor SOPs and regulatory guidelinesQualification• Master's degree in Pharmacy• Doctor's degree in Pharmacy• Master’s degree in Life Sciences• Educated to at least GCSE level or equivalent (as applicable)Experience• 0–1 year of experience in Drug Safety / Pharmacovigilance• Exposure to clinical trials preferred• Academic or project experience in safety data handling will be an advantageSkills• Knowledge of MedDRA and WHODD coding• Understanding of ICH guidelines and pharmacovigilance processes• Ability to handle safety databases and documentation• Strong analytical and attention-to-detail skills• Good communication and stakeholder coordination abilities• Ability to manage timelines and work in a team environmentAbout the OrganizationFortrea is a global contract research organization (CRO) providing clinical development and pharmacovigilance services to pharmaceutical, biotechnology, and medical device companies, supporting drug safety and regulatory compliance worldwide.

Roles & Responsibilities• Perform data entry of safety data into adverse event tracking systems• Write patient narratives and accurately code adverse events using MedDRA and WHODD (for marketed products, if applicable)• Assist in listedness assessment against appropriate product labels (for marketed products, if applicable)• Support causality assessment activities under supervision• Generate queries and collect missing or discrepant information in consultation with medical staff, if required• Assist in submission of expedited SAE/SUSAR reports to clients, regulatory authorities, ethics committees, investigators, third-party vendors, partners, and internal project personnel within agreed timelines• Support preparation, review, and approval of Periodic Safety Reports (PSRs) for investigational products/devices in accordance with applicable regulations and guidelinesQualification• Educated to at least GCSE level or equivalent• Master’s degree in Life ScienceExperience• 0 to 1 year of experience in Drug Safety• Strong exposure to Clinical Trials preferredSkills• Knowledge of adverse event reporting and safety databases• Understanding of MedDRA and WHODD coding• Ability to manage multiple tasks in a structured environment• Strong collaboration skills with internal and external stakeholders• Attention to detail and regulatory compliance mindsetAbout The CompanyFortrea is a global contract research organization (CRO) providing clinical development and pharmacovigilance services to pharmaceutical, biotechnology, and medical device companies. The organization supports drug safety, regulatory compliance, and clinical trial operations worldwide, operating in alignment with global standards and sponsor requirements.

Roles & Responsibilities:• Perform data entry of adverse event reports into the pharmacovigilance (PV) database• Assess seriousness and causality of adverse event cases as per regulatory guidelines• Validate data against source documents and call notes for accuracy• Ensure completeness, correctness, and quality of cases prior to regulatory submission• Identify potential delays in case processing and escalate issues appropriately• Determine need for follow-up information and ensure timely case closure• Comply with internal and global timelines for adverse event and product complaint processing• Maintain adherence to global and local pharmacovigilance regulations• Meet expected productivity and quality benchmarks• Actively participate in team meetings and support assigned PV activitiesQualification:• Veterinarian (equivalent to US DVM degree) with or without pharmacovigilance experience OR• Bachelor’s degree in Life Sciences with 0–2 years of pharmacovigilance experience• Bachelor of Pharmacy, Master of Pharmacy, Docotor of PharmacyExperience:• 0–2 years of experience in pharmacovigilance / adverse event case processing preferredSkills:• Basic knowledge of medical terminology relevant to pharmacovigilance• Understanding of global and local regulatory requirements• Strong attention to detail and data accuracy• Effective written and verbal communication skills• Ability to manage multiple products and priorities simultaneously• Proficiency in working with multiple databases• Flexibility to manage high-volume case processing• Self-motivated and adaptable to dynamic environmentsAbout the Organization:Elanco is a global leader in animal health dedicated to innovation in preventing and treating diseases in farm animals and pets, fostering a diverse and inclusive culture focused on improving animal health worldwide.

Role & Responsibilities• Solve routine problems with reference to general guidelines.• Interact primarily within your own team and with your direct supervisor.• Follow detailed to moderate level instructions on daily tasks and new assignments.• The decisions made will impact your own work.• Work as an individual contributor as part of a team, with a focused scope of work.• May require working in rotational shifts.Qualification• Bachelor of Pharmacy / Master of Pharmacy.Experience• 1 to 3 years of experience in pharmacovigilance or drug safety operations.Vacancies• 1 VacancySkills• Proficiency in pharmacovigilance and drug safety surveillance.• Experience with case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs.• Understanding of global regulatory requirements related to pharmacovigilance.• Ability to monitor and assess the safety of pharmaceutical products.• Familiarity with clinical trials data and healthcare provider data analysis.• Ability to solve routine problems through guidelines.About The CompanyAccenture is a global professional services company with leading capabilities in digital, cloud, and security. The company offers strategy and consulting, technology and operations services, and Accenture Song.

Roles & Responsibilities:• Assist in processing Individual Case Safety Reports (ICSRs)• Perform adverse event (AE) and serious adverse event (SAE) case intake• Support case triage, data entry, and quality checks• Ensure compliance with global pharmacovigilance regulations• Work with medical terminologies such as MedDRA and WHO-DD• Maintain accurate drug safety documentation• Collaborate with senior drug safety associates and PV teamsQualification:• M.Pharm / B.Pharm / PharmD / MSc Life SciencesExperience:• Freshers onlyNo. of Openings: 30Skills:• Basic understanding of Pharmacovigilance and drug safety processes• Awareness of adverse events and clinical pharmacology• Familiarity with medical terminology• Good attention to detail and willingness to learnAbout the Organization:The company is a global pharmaceutical organization with established pharmacovigilance operations, offering freshers hands-on exposure and a strong foundation in drug safety and clinical safety operations.Interested and eligible candidates should share their updated CV to email: sahana.s@randstad.in

Roles & Responsibilities• Assist with overall safety trackers, applications, and tools implementation, support, configuration, and migration activities• Provide service to clients either as a support function to client project groups or as a standalone business• Ensure delivery of high-quality service to internal and external clients in a safe and cost-effective manner• Conduct project-specific configurations in safety applications/tools• Maintain and document trackers/applications/tools configuration based on requirements and updates• Evaluate proposed project ideas or software changes through technical impact analysis and estimated business value• Develop and document standard and ad hoc reports from safety trackers/applications/tools• Support and educate end users and sponsors as needed• Collaborate with training teams to develop safety application/tool-specific training modules• Document user requirements and ensure timely delivery in collaboration with technical partners• Provide guidance on use of standard safety trackers/tools, including advanced conditions and Standard MedDRA Queries (SMQ)• Conduct routine and ad hoc data extraction (e.g., PSURs, DSURs, 6-monthly listings)• Participate in data migration activities and related documentation• Support change management and user training for trackers/tools• Manage ticketing, issue resolution, and escalate issues as needed• Respond to mailbox queries and provide vendor management support• Train team members on technical and functional aspects of safety tools• Update departmental SOPs, working practices, and guidelines• Monitor tracker/tool failures and resolve issues promptly• Perform user acceptance testing and complete required documentation• Lead critical team projects and manage team workloadQualification• Degree in Life Sciences, IT, or Computing (relevant equivalent experience may be considered)Experience• Minimum 2 years in safety trackers/applications/tools operations support• Experience with validated document management systems and drug safety trackers (e.g., intake/SAE/ESR trackers, SharePoint, in-house tools)• Clinical background with clinical systems is preferredSkills• Strong technical and functional knowledge of PV systems• Good understanding of SQL and ticket support applications• Proficiency in Microsoft Office tools• Strong attention to detail and ability to handle multiple priorities• Good written and verbal communication skills• Ability to work collaboratively and provide peer supportAbout the CompanyFortrea is a global leader in clinical research and pharmacovigilance services, providing innovative solutions for drug safety, clinical trial operations, and regulatory compliance. With a presence in India and worldwide, Fortrea offers professionals exposure to advanced clinical technologies, validated systems, and global trial operations while fostering a collaborative and high-quality service-driven work culture.

Roles & Responsibilities• Perform end-to-end clinical data management activities for assigned studies• Review and evaluate clinical trial imaging and clinical data for accuracy and compliance• Collaborate with project teams to define study-specific edit checks• Run, review, and resolve data queries and discrepancies• Support study setup including database structure, specifications, and TF design• Coordinate receipt, integration, and processing of external and electronic clinical data• Maintain complete, accurate, and audit-ready study documentation• Track open data issues and ensure timely resolution• Ensure CDM activities comply with regulatory guidelines and internal SOPs• Participate in client meetings and cross-functional discussions• Continuously enhance technical and industry knowledge through trainingQualification• Bachelor’s degree in Life Sciences, Computer Science, or a related discipline• Equivalent clinical data management experience will be consideredExperience• Minimum 1 year of experience in Clinical Data Management (Pharma, Biotech, or CRO)Skills• Strong understanding of clinical trial terminology and CDM processes• Working knowledge of relational databases and data validation• SAS knowledge is desirable• Proficiency in MS Word, Excel, and Access• Strong analytical skills with high attention to detail• Excellent documentation, organizational, and communication skills• Ability to work independently and effectively in fast-paced team environmentsAbout the OrganisationClario is a global leader in clinical trial endpoint technology, delivering innovative imaging, cardiac safety, and digital endpoint solutions to support clinical trials worldwide. The company partners with leading pharmaceutical, biotech, and medical device organizations, offering professionals exposure to global studies, advanced technology platforms, and diverse therapeutic areas.