Pharmacovigilance Jobs in Mumbai

Why This Role MattersPharmacovigilance professionals play a critical role in safeguarding public health by monitoring, evaluating, and reporting drug safety data. Aggregate safety reports such as PADERs, PSURs, PBRERs, and Risk Management Plans (RMPs) are essential regulatory documents that ensure ongoing benefit-risk evaluation of medicinal products.As an Officer – Pharmacovigilance at Unichem Laboratories, you will contribute directly to global drug safety compliance, regulatory reporting accuracy, and adherence to international standards such as FDA, ICH-GCP, and GVP guidelines. This role is ideal for pharmacy professionals aiming to build a strong career in drug safety and regulatory science.Job DescriptionUnichem Laboratories is hiring for the position of Officer – Pharmacovigilance (Aggregate Report Drafting) in Mumbai. This is a full-time, permanent opportunity for professionals with 1–6 years of pharmacovigilance experience, particularly in aggregate safety reporting.The selected candidate will be responsible for drafting, reviewing, and maintaining periodic safety reports and ensuring compliance with global regulatory requirements. The role also involves supporting pharmacovigilance operations, conducting training sessions, and collaborating with Medical Affairs and other internal stakeholders.Key Responsibilities• Support execution of pharmacovigilance (PV) activities• Prepare and maintain PV documents, SOPs, and Work Instructions (WIs)• Draft and review aggregate safety reports, including:• Periodic Adverse Drug Experience Reports (PADERs)• Periodic Safety Update Reports (PSURs)• Periodic Benefit-Risk Evaluation Reports (PBRERs)• Risk Management Plans (RMPs)• Ensure compliance with company SOPs and global regulatory requirements• Monitor regulatory authority websites for safety updates and compliance changes• Provide accurate responses to medical information queries• Conduct PV training sessions for internal teams, manufacturing plants, and vendors• Support Medical Affairs in pharmacovigilance-related inquiriesThis position provides comprehensive exposure to global drug safety regulations and aggregate report drafting processes.Eligibility CriteriaEducational Qualification:• B.Pharm (Bachelor of Pharmacy)• M.Pharm (Any Specialization Preferred)Experience:• 1–6 years of pharmacovigilance experience• Hands-on experience in aggregate safety report drafting preferredDesired Skills & Competencies• Strong understanding of international regulatory requirements including FDA, ICH-GCP, and GVP Modules• Knowledge of EU Clinical Trial Directive• Experience in pharmacovigilance aggregate report drafting• Excellent written and verbal communication skills• Strong analytical and decision-making abilities• High attention to detail in drug safety documentation• Ability to work effectively in dynamic, cross-functional teamsSalary & BenefitsCompensation: Competitive salary aligned with industry standards, based on experience and expertise.Additional Benefits:• Opportunity to work with a reputed pharmaceutical organization• Exposure to global regulatory frameworks (FDA, ICH, GVP)• Strong career progression in pharmacovigilance and drug safety• Corporate exposure in a Mumbai-based pharmaceutical setup• Professional development in regulatory documentation and complianceCompany OverviewUnichem Laboratories is a well-established pharmaceutical company engaged in the development, manufacturing, and marketing of pharmaceutical formulations and active pharmaceutical ingredients.The organization emphasizes regulatory compliance, quality standards, and global pharmacovigilance practices. Working at Unichem offers professionals exposure to structured drug safety systems and international reporting standards.FAQsQ: Is aggregate report drafting experience mandatory?Experience in drafting PADERs, PSURs, PBRERs, or RMPs is highly preferred for this role.Q: What level of experience is required?Candidates with 1–6 years of pharmacovigilance experience are eligible to apply.Q: Is this role focused only on documentation?The primary focus is aggregate report drafting, but it also includes PV compliance monitoring, training, and coordination with Medical Affairs.Q: Where is the job location?The position is based in Mumbai.Application Tips• Highlight specific aggregate reports you have drafted or reviewed• Mention exposure to FDA, ICH-GCP, and GVP guidelines• Showcase analytical skills and experience in benefit-risk evaluation• Demonstrate familiarity with SOP-based environments• Prepare to discuss regulatory inspection or audit exposure

Why This Role MattersPharmacovigilance Agreements (PVAs) are critical legal and operational documents that define safety responsibilities between marketing authorization holders and partners. A well-drafted and compliant PVA ensures clear accountability, regulatory compliance, and seamless safety data exchange across global stakeholders.At Tata Consultancy Services (TCS), this role supports global clients within Business Process Services by drafting, reviewing, and managing PVAs in alignment with international pharmacovigilance regulations and company standards.Job DescriptionTCS is hiring experienced Pharmacovigilance professionals for the role of Executive / Senior Executive – Pharmacovigilance Agreements Specialist in Mumbai.The position focuses on drafting, reviewing, maintaining, and monitoring Global and Local Pharmacovigilance Agreements while ensuring compliance with ICH guidelines and Good Pharmacovigilance Practices (GVP).Key Features of the Role• Draft and review Global and Local Pharmacovigilance Agreements (PVAs)• Ensure compliance with ICH and global GVP regulations• Manage PVA trackers, repositories, and reconciliation activities• Monitor compliance of effective PVAs and prepare dashboards• Coordinate with cross-functional and client stakeholders• Manage PVA mailbox and communication workflows• Support project documentation and operational updatesResponsibilities• Draft new PVAs and revise existing agreements as per company standards• Review PVAs for quality, completeness, and regulatory alignment• Address internal and collaborating company comments on agreements• Manage dedicated PVA mailbox and ensure timely communication• Announce new or revised PVAs to relevant stakeholders• Maintain and update global PVA trackers including reconciliation activities• Perform compliance monitoring of active PVAs and prepare dashboards• Upload and maintain PVA documentation in company repository systems• Assist Project Manager or designee in updating project trackers and documentation• Attend team meetings and provide updates on PVA status and operational issuesRequired Qualifications• 3–7 years of experience in Pharmacovigilance• Strong knowledge of global pharmacovigilance regulations (ICH, GVP Modules)• Hands-on expertise in drafting and managing Global and Local PV Agreements• Experience handling contractual pharmacovigilance arrangementsEducational Requirements• Bachelor of Pharmacy (B.Pharm)• Master of Pharmacy (M.Pharm)• Bachelor of Science (B.Sc)• Master of Science (M.Sc)Experience and Skills• Strong understanding of contractual PV obligations• Experience managing PVA trackers and compliance dashboards• Knowledge of global regulatory frameworks and safety exchange processes• Excellent documentation, communication, and stakeholder coordination skills• Proficiency in MS Office tools• Ability to manage multiple agreements and timelines simultaneouslySalary Insights• Competitive compensation aligned with experience• Opportunity to work with global pharmaceutical clients• Exposure to international contractual pharmacovigilance frameworksFAQsQ: Is prior PVA drafting experience mandatory?Yes, hands-on experience with Global and Local PV Agreements is required.Q: Does the role involve client interaction?Yes, coordination with collaborating companies and internal stakeholders is part of the role.Q: Is regulatory knowledge important?Strong understanding of ICH and GVP modules is essential.Application Tips• Clearly mention PVA drafting and review experience• Highlight exposure to global pharmacovigilance regulations• Include examples of compliance monitoring or dashboard preparation• Emphasize stakeholder coordination and documentation management skills

Why This Role MattersPharmacovigilance (PV) training is critical to ensure that all employees, subsidiaries, partners, and vendors are aware of global safety standards, regulatory requirements, and internal processes. Well-trained personnel reduce compliance risks, improve safety data quality, and support overall regulatory adherence.In this role at Fidelity Health Services, you will manage global PV and non-PV training programs, track compliance, and contribute to the development of departmental processes and training methodologies. This position directly impacts the competency and readiness of teams operating across multiple geographies.Job DescriptionFidelity Health Services is hiring an Executive / Senior Executive to lead and manage pharmacovigilance training initiatives. Based in Navi Mumbai, this role involves planning, executing, and monitoring PV and non-PV training activities for employees, subsidiaries, partners, and vendors globally.The role requires coordination with internal teams, e-learning platforms, and global stakeholders to ensure compliance with regulatory training requirements. You will also maintain training records, update documentation, and contribute to process improvements.Key Features of the Role• Manage global PV and non-PV training programs• Oversee e-learning systems and portals for effective training delivery• Track training compliance and generate reports for management• Maintain accurate training documentation and records• Contribute to SOP, Work Instructions (WI), and Working Practice System (WPS) updates• Support departmental process improvements and methodology development• Perform impact analysis for PV training compliance strategiesResponsibilities• Plan and manage pharmacovigilance and non-pharmacovigilance training programs globally• Administer and maintain e-learning platforms and portals• Track employee and partner compliance with mandatory training• Conduct cyclical review and updates of training-related documentation• Manage documentation for all training activities, including records and reports• Assist in developing departmental processes, procedures, and best practices• Provide inputs into SOPs, WIs, WPS, and other relevant procedural documents• Perform impact analysis of training compliance and recommend improvementsRequired Qualifications• 2–4 years of experience in training management within a pharmaceutical or healthcare environment• Experience in pharmacovigilance training is preferred but not mandatory• Familiarity with e-learning platforms and compliance tracking systems• Strong documentation and organizational skillsEducational Requirements• Bachelor of Pharmacy (B.Pharm)• Master of Pharmacy (M.Pharm)• Bachelor of Ayurvedic Medicine & Surgery (BAMS)• Bachelor of Homeopathic Medicine & Surgery (BHMS)Experience and Skills• Ability to plan and deliver training programs across multiple regions• Knowledge of pharmacovigilance processes and compliance requirements• Excellent communication and interpersonal skills• Strong analytical and organizational skills• Experience managing global stakeholders and training portalsSalary Insights• Competitive salary based on experience and qualification• Career growth within PV and global training management• Exposure to multinational operations and regulatory training complianceCompany OverviewFidelity Health Services is a global provider of pharmacovigilance and regulatory compliance services. The organization supports multinational pharmaceutical companies with PV operations, training, aggregate reporting, and safety compliance. Fidelity Health Services emphasizes process excellence, global regulatory adherence, and continuous development of personnel.FAQsQ: Is prior PV experience mandatory?Experience in PV is preferred but candidates with general pharmaceutical training experience will also be considered.Q: Does the role involve global stakeholders?Yes, the role manages training for employees, subsidiaries, partners, and vendors worldwide.Q: Are e-learning systems used?Yes, the candidate will manage and maintain e-learning platforms and compliance portals.Application Tips• Highlight experience in training coordination and compliance tracking• Include exposure to e-learning management systems• Showcase ability to manage documentation and updates for SOPs, WIs, and WPS• Demonstrate familiarity with PV or regulatory training processes

Why This Role MattersDrug Safety Specialists play a crucial role in ensuring accurate reconciliation, regulatory compliance, and effective exchange of global safety information. Strong reconciliation and compliance monitoring processes protect patient safety and maintain regulatory trust.At Fidelity Health Services, this role supports global pharmacovigilance operations by managing safety reconciliation activities, reference safety information updates, and regulatory database reviews.Job DescriptionFidelity Health Services is hiring an Executive / Senior Executive – Drug Safety Specialist for its Navi Mumbai location. The role focuses on safety reconciliation, compliance monitoring, global safety information exchange, and regulatory data review.The selected candidate will coordinate with internal PV teams and global stakeholders to ensure accurate reconciliation of safety data and timely documentation updates.Key Features of the Role• Exposure to global pharmacovigilance operations• Hands-on experience in safety reconciliation and compliance monitoring• Interaction with regulatory safety databases• Involvement in global product lifecycle safety management• Opportunity to grow within drug safety operationsResponsibilities• Manage safety reconciliation and compliance monitoring activities for clients• Perform reconciliation of Reference Safety Information (RSI) for client products• Conduct data mining and review of FDA’s Adverse Event Reporting System (FAERS) and other regulatory databases• Edit, review, and reconcile Consolidated Global Product Lists• Manage global exchange of safety information for product approvals, launches, cancellations, and RSI updates• Maintain and update documentation related to safety reconciliation• Coordinate with cross-functional teams for issue resolution• Ensure regulatory compliance and audit readinessRequired Qualifications• 5–8 years of experience in the Pharmacovigilance domain• Strong experience in safety reconciliation and compliance monitoring• Proficiency in MS Excel• Experience in mailbox management and safety communication trackingEducational Requirements• Bachelor of Pharmacy (B.Pharm)• Master of Pharmacy (M.Pharm)Experience and Skills• Strong understanding of pharmacovigilance processes• Experience with global safety information exchange workflows• Knowledge of FAERS and regulatory safety databases• Analytical and detail-oriented approach• Good documentation and coordination skills• Ability to manage multiple client deliverables and timelinesSalary Insights• Competitive compensation based on experience• Exposure to global drug safety projects• Career progression opportunities in reconciliation and complianceCompany OverviewFidelity Health Services provides end-to-end pharmacovigilance and regulatory services to global pharmaceutical companies. The organization specializes in safety reconciliation, aggregate reporting, compliance monitoring, and regulatory documentation support.FAQsQ: Is prior reconciliation experience mandatory?Yes, hands-on experience in safety reconciliation is required.Q: Does the role involve regulatory database review?Yes, including FAERS and other global safety databases.Q: Is this a client-facing role?The role involves coordination with clients and internal PV teams.Application Tips• Highlight reconciliation experience clearly• Mention exposure to FAERS or regulatory databases• Showcase Excel proficiency (pivot tables, tracking sheets)• Include examples of compliance monitoring or audit support experience

Why This Role MattersPharmacovigilance reconciliation and compliance monitoring are critical to maintaining global drug safety standards. Accurate reconciliation of safety data ensures consistency between regulatory submissions, reference safety information (RSI), and global product databases—ultimately safeguarding patient health and maintaining regulatory compliance.At Fidelity Health Services, this role plays a key part in managing global safety information exchange, reconciliation activities, and compliance oversight for multiple clients.Job DescriptionFidelity Health Services is seeking experienced Pharmacovigilance professionals for its Navi Mumbai location. The position focuses on safety reconciliation, compliance monitoring, RSI management, and global exchange of safety information across product lifecycles.The selected candidate will support client-specific safety operations, manage global product listings, and ensure regulatory alignment with international pharmacovigilance requirements.Key Features of the Role• Exposure to global pharmacovigilance operations• Involvement in safety reconciliation and compliance monitoring• Interaction with international regulatory databases (e.g., FAERS)• Management of global safety information exchange• Opportunity to work with multinational client portfoliosResponsibilities• Manage safety reconciliation activities for assigned clients• Perform reconciliation of Reference Safety Information (RSI)• Conduct data mining and review of FDA’s FAERS and other regulatory databases• Edit, review, and reconcile Consolidated Global Product Lists• Manage global exchange of safety information related to product approvals, launches, cancellations, and RSI updates• Monitor compliance metrics and reporting timelines• Maintain and update safety reconciliation documentation• Ensure data accuracy and regulatory compliance• Coordinate with cross-functional PV and regulatory teams• Support audit readiness and documentation reviewsRequired Qualifications• 5–8 years of experience in Pharmacovigilance domain• Hands-on experience in safety reconciliation and compliance monitoring• Experience working with global regulatory databases• Proficiency in MS Excel and mailbox managementEducational Requirements• Bachelor of Pharmacy• Master of PharmacyExperience and Skills• Strong understanding of global PV regulations• Experience in RSI reconciliation and safety database review• Knowledge of FAERS and regulatory data mining• Good analytical and documentation skills• Strong attention to detail and compliance mindset• Ability to manage multiple client deliverables• Effective communication and coordination skillsSalary Insights• Competitive compensation based on PV experience• Exposure to global pharmacovigilance operations• Growth opportunities in safety compliance and regulatory functionsCompany OverviewFidelity Health Services is a pharmacovigilance and regulatory support organization providing end-to-end drug safety services to global pharmaceutical clients. The company specializes in safety operations, reconciliation management, and compliance monitoring in regulated markets.FAQsQ: Is reconciliation experience mandatory?Yes, hands-on experience in safety reconciliation is required.Q: Is FAERS knowledge important?Yes, data mining and review of FAERS and regulatory databases is a key responsibility.Q: Does the role involve global coordination?Yes, management of global safety information exchange is part of the role.Application Tips• Highlight reconciliation projects handled• Mention RSI management experience• Include exposure to FAERS or regulatory databases• Emphasize Excel proficiency and compliance monitoring expertise

Why This Role MattersPharmacovigilance plays a critical role in protecting patient safety by monitoring, detecting, and preventing adverse drug reactions. As a Pharmacovigilance Associate at Tata Consultancy Services, you will contribute directly to global drug safety operations, ensuring regulatory compliance and supporting pharmaceutical clients in maintaining high-quality safety standards. This role is essential in strengthening patient trust, maintaining regulatory integrity, and supporting life sciences innovation through structured safety monitoring and reporting.Job DescriptionTata Consultancy Services is hiring Pharmacovigilance Associates to support adverse event case processing, safety data management, and regulatory compliance activities. The selected candidate will be responsible for reviewing and processing Individual Case Safety Reports (ICSRs), performing drug safety data entry and validation, and ensuring accurate and timely submission of regulatory reports. The role requires hands-on experience with safety databases such as Argus or ARISg and strong knowledge of global pharmacovigilance regulations.Key Features of the Role:• Exposure to global pharmacovigilance operations• Opportunity to work with leading pharmaceutical clients• Hands-on experience with Argus Safety and ARISg databases• Involvement in signal detection and risk assessment support• Cross-functional collaboration within life sciences teams• Competitive salary structure aligned with industry standardsResponsibilities• Process and review adverse event case reports• Perform drug safety data entry and validation• Ensure compliance with global pharmacovigilance regulations• Work on safety databases such as Argus or ARISg• Conduct case follow-ups and resolve safety queries• Prepare and review case narratives• Maintain accuracy and completeness of safety data• Collaborate with cross-functional teams for safety reporting• Support signal detection and risk assessment activities• Participate in audits and regulatory inspections• Maintain documentation as per SOPs and guidelines• Ensure timely submission of regulatory reports• Identify discrepancies and resolve safety data issues• Assist in quality control and compliance checksRequired Qualifications• University Graduate (Life Sciences, Pharmacy, Biotechnology, Nursing, or related field preferred)• 2–4 years of experience in pharmacovigilance or drug safety• Experience in ICSR processing and case management• Hands-on knowledge of Argus Safety or ARISgEducational Requirements:• Bachelor’s degree in Pharmacy, Life Sciences, Biotechnology, or related discipline• Relevant certification in Pharmacovigilance preferredExperience and Skills:• Strong understanding of pharmacovigilance and drug safety processes• Expertise in ICSR case processing• Knowledge of global regulatory compliance requirements• Proficiency in Argus Safety or ARISg• Good understanding of medical terminology• Strong analytical and data review skills• Attention to detail and quality-focused mindset• Effective communication and documentation skills• Ability to work within defined timelines and SOP frameworksAge Eligibility:No specific age criteria mentioned. Candidates must meet educational and experience requirements.Salary Insights₹4,00,000 – ₹8,00,000 per annum (based on experience and expertise). Compensation may vary depending on candidate profile, project allocation, and skill level.Company OverviewTata Consultancy Services (TCS) is a global IT services, consulting, and business solutions organization delivering technology-driven solutions to leading enterprises worldwide. With a strong presence in life sciences and healthcare domains, TCS supports pharmaceutical and biotech organizations in pharmacovigilance, regulatory operations, clinical research, and digital transformation initiatives. TCS operates across multiple countries and is known for innovation, operational excellence, and client-centric solutions.FAQs1. Is experience in Argus mandatory?Experience in Argus or ARISg is strongly preferred.2. Is this a client-facing role?The role involves collaboration with internal and external stakeholders in safety reporting.3. Is remote work available?Location is specified as Mumbai / Pune; work model depends on project allocation.4. What growth opportunities are available?Career progression may include Senior PV Associate, Drug Safety Specialist, or Quality Reviewer roles.Application Tips• Highlight ICSR processing and case narrative experience clearly• Mention safety database expertise (Argus/ARISg) prominently• Showcase knowledge of global PV regulations• Quantify case volume handled per month if possible• Emphasize audit experience and compliance adherence• Tailor your CV specifically for pharmacovigilance keywords

Roles & Responsibilities• Compile, review, and submit regulatory dossiers in eCTD format for US (FDA), Europe (EU), CDSCO, and other regulated markets• Manage Drug Master Files (DMFs) including preparation, review, updates, and full lifecycle management• Maintain and update regulatory databases for submissions, lifecycle changes, LOAs, Applicant Parts, and Restricted Parts• Plan and submit annual reports, amendments, and variations within defined regulatory timelines• Prepare and submit responses to regulatory authority and customer queries• Issue No Objection Certificates (NDCs) and ensure timely database updates• Review and approve change controls, deviations, and QMS documentation• Ensure compliance with global regulatory requirements for APIs and peptides• Coordinate cross-functionally with QA, Production, and R&D for regulatory alignmentQualification• M.Sc / M.Pharm ( Master of Pharmacy) / B.Pharm (Bachelor of Pharmacy) from a recognized institutionExperience• 8–15 years of experience in Regulatory Affairs• Strong experience in API / Peptides manufacturing• Hands-on experience with DMF submissions and lifecycle management for US FDA, EU, and CDSCOSkills• In-depth knowledge of global regulatory requirements (US FDA, EU, CDSCO)• Expertise in DMF preparation and submission processes• Strong understanding of APIs and Peptides regulatory frameworks• Regulatory database management and documentation control• Analytical thinking and problem-solving ability• Strong communication and leadership skills• Ability to manage multiple projects in a fast-paced environmentAbout the OrganizationPiramal Pharma Limited is a leading global pharmaceutical company specializing in APIs, complex generics, and contract development and manufacturing services, committed to innovation, regulatory excellence, and patient-centric healthcare solutions worldwide.

Roles & Responsibilities• Distribute medical safety documents to internal stakeholders, affiliates, and license partners• Process, format, and archive periodic safety reports and Risk Management Plans (RMP)• Perform eCTD formatting and document publishing as per global pharmacovigilance regulations• Act as GPV Business Administrator for the DARIUS Document Management System• Manage GPV-specific documents and oversee archiving activities in DARIUS• Maintain electronic archives, SharePoint drives, and document repositories• Support pharmacovigilance inspections and audits through back-office documentation support• Serve as Deputy PSMF Coordinator and assist in maintaining the Pharmacovigilance System Master File (PSMF)• Provide PSMF documentation to regulatory authorities upon request• Ensure compliance with global safety reporting requirements and document lifecycle management standardsQualification• B.Pharm, M.Pharm, Pharm.D, MSc, BSc (Life Sciences) or equivalent qualification• Industrial Business Management Assistant / Documentation Specialist qualification preferredExperience• Minimum 3 years of experience in pharmacovigilance documentation or safety reporting• Strong experience in eCTD formatting and publishing• Experience handling PSUR, DSUR, PBRER, and RMP documentation• Experience with DARIUS Document Management System• Experience in PSMF maintenance and regulatory documentationVacancies• 1 VacancySkills• Advanced knowledge of global pharmacovigilance terminology and regulations• Strong expertise in document management systems• Proficiency in Microsoft Excel, Word, PowerPoint, and Outlook• Knowledge of SharePoint and e-room technology• Basic HTML knowledge preferred• Strong multitasking and organizational skills• Detail-oriented approach with audit readiness exposure• Excellent written and verbal English communication skillsAbout the CompanyAbbott is a leading global healthcare and research-driven organization focused on innovation across pharmaceuticals, diagnostics, medical devices, and nutrition. With a strong presence in Research & Development, Abbott provides opportunities to work on global pharmacovigilance systems, regulatory compliance frameworks, and safety documentation processes aligned with international standards.

Roles & Responsibilities• Support and manage local Pharmacovigilance operations in India• Act as Deputy Pharmacovigilance Officer-in-Charge (PVOIC)• Assist Local PV Responsible Person in meeting regulatory and compliance obligations• Oversee end-to-end ICSR management including intake, processing, review, and submission• Conduct literature surveillance and ensure timely safety reporting• Maintain and update Pharmacovigilance System Master File (PSMF)• Oversee safety reporting for marketed products, clinical studies, and special programs• Ensure compliance with local and global PV regulations• Support preparation and submission of PSUR/PBRER• Implement and maintain Risk Management Plans (RMPs)• Contribute to signal detection, evaluation, and escalation activitiesQualification• M.Pharm / Pharm.D / MBBS / Life Sciences (relevant qualification preferred)Experience• 5+ years of Pharmacovigilance experience• Strong experience in India PV regulations (mandatory)• Experience in local PV operations and regulatory complianceSkills• Strong knowledge of Indian and global PV regulations• Expertise in ICSR lifecycle management and literature review• Hands-on experience in PSMF maintenance and RMP implementation• Experience in PSUR/PBRER preparation and submission• Signal detection and risk evaluation skills• Strong leadership and stakeholder coordination abilities• Excellent documentation and communication skillsAbout the CompanyDomnic Lewis has been mandated by a Global Pharmaceutical MNC to recruit for this strategic Pharmacovigilance leadership role. The organization operates in highly regulated markets and emphasizes strong compliance, patient safety, and regulatory excellence while offering growth opportunities in local and global PV operations.

Roles & Responsibilities:• Manage Product Life Cycle Management (LCM) activities in line with regulatory guidelines• Ensure compliance with applicable regulatory requirements and internal SOPs• Maintain and update internal regulatory databases and tracking systems• Keep regulatory archives updated with valid licenses, approvals, and labelling documents• Coordinate with internal and external stakeholders for change management activities• Assist in electronic formatting and compilation of global regulatory submissions (eCTD)• Support preparation and review of global filing documentation as per agency guidance• Perform documentation control, archival, and administrative regulatory tasks• Support regulatory submissions in compliance with ICH and EU requirementsQualification:• Bachelor degree in Pharmacy, Master of Pharmacy• Bachelor’s Degree in Science from a reputed College/UniversityExperience:• 2–3 years of experience in Regulatory Affairs or regulated pharmaceutical industrySkills:• Knowledge of Product Lifecycle Management (PLM)• Understanding of EU regulatory requirements and ICH guidelines• Experience in eCTD submissions and electronic publishing• Proficiency in MS Office (Word, Excel, PowerPoint, Outlook)• Strong documentation, tracking, and archival skills• Familiarity with regulatory software systems• Ability to work independently and collaboratively in cross-functional teams• Fluency in English (written and verbal communication)About the Organization:Orion Pharma is a globally operating pharmaceutical organization focused on delivering innovative and high-quality medicines while maintaining strong regulatory compliance across international markets.

Roles & Responsibilities• Perform batch documentation review and support batch release activities for products listed on Aspire Pharma’s MIA and third-party MIAs• Review stability data and ensure compliance with approved specifications• Manage deviations, non-conformances, CAPAs, and change control activities• Support MIA product setup, batch release documentation, and launch readiness activities• Conduct monthly compliance checks and contribute to product launch activities• Maintain up-to-date knowledge of EU/UK GxP regulations, including GMP, GDP, GVP, and GCP• Ensure compliance with regulations related to medical devices (ISO 9001, ISO 13485, ISO 14971), controlled drugs, nutritional products, GDPR, and the UK Data Protection Act• Communicate effectively with internal teams, vendors, and customers to implement regulatory changes• Investigate non-conformances and deviations and support corrective and preventive actions• Monitor vendor performance to ensure compliance and supply continuity• Update quality procedures and documentation in line with legislative and regulatory requirementsQualification• Bachelor’s degree in Science or related disciplineExperience• 5–8 years of relevant experience in Quality Assurance or Technical Compliance (desirable)• Experience with MIA batch review and release activities (desirable)• Strong understanding of pharmaceutical regulatory and compliance requirementsSkills• Excellent written and spoken English communication skills• Strong time management and organizational abilities• High attention to detail and documentation accuracy• Proactive team player with problem-solving mindset• Proficiency in MS Office (Word, Excel, Outlook)• Experience with Adobe Acrobat and electronic signature tools (desirable)• Familiarity with Q-Pulse or other electronic QMS systems (desirable)About the CompanyAspire Pharma is a UK-based asset-light pharmaceutical manufacturer with a diversified portfolio of over 250 products across urology, ophthalmology, CNS, dermatology, and specialty generics, delivering innovative and reliable healthcare solutions to underserved markets worldwide.

Roles & Responsibilities• Collect, review, and process Adverse Event (AE) and Serious Adverse Event (SAE) reports• Perform case processing and data entry in safety databases such as Argus, ARISg, Oracle, or similar systems• Conduct literature searches and review scientific publications for safety-related information• Assist in signal detection, risk assessment, and safety trend analysis• Ensure compliance with ICH-GCP, ICH-E2B, and applicable regulatory guidelines• Support preparation and review of PSURs, PBRERs, and other regulatory safety documents• Maintain accurate, complete, and audit-ready pharmacovigilance documentation• Coordinate with Clinical, Regulatory, Quality, and other cross-functional teams• Follow SOPs, timelines, and quality standards for safety reportingQualification• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biotechnology, or related disciplineExperience• Freshers are eligible to apply• Internship or academic exposure to pharmacovigilance or clinical research is an advantageSkills• Basic understanding of pharmacovigilance concepts and safety reporting• Knowledge of ICH-GCP and global drug safety regulations• Strong attention to detail and documentation skills• Good written and verbal communication skills• Ability to work in a team-oriented and compliance-driven environment• Willingness to learn safety databases and PV workflowsAbout the OrganisationThe organization is a growing healthcare and life sciences company focused on ensuring patient safety and regulatory compliance through high-quality pharmacovigilance and drug safety services, offering strong learning and career development opportunities for fresh graduates.

Roles & Responsibilities• Perform medical review of clinical, spontaneous, solicited, and literature adverse event cases (ICSRs)• Assess seriousness, causality, labeling, and overall medical accuracy of safety cases• Review narratives, AE/SAE terms, suspect drugs, concomitant medications, laboratory data, and medical history• Ensure compliance with global and local regulatory guidelines and adherence to SOP timelines• Provide medical inputs and product-related guidance to Drug Safety teams• Generate, send, and track medical follow-up queries• Review and respond to case-related queries within safety databases• Support audits, internal reviews, and client discussions• Provide medical input for SUSARs and other critical safety casesQualification• MBBS or equivalent (mandatory)Experience• Minimum 3+ years of experience in Pharmacovigilance / Drug Safety• Prior experience in medical review of ICSRs preferredSkills• Strong medical and clinical knowledge• Solid understanding of Pharmacovigilance and Drug Safety processes• Good problem-solving and decision-making abilities• Proficiency with MS Office and safety databases• Excellent written and verbal communication skills• Ability to work effectively in a multi-disciplinary team• High attention to detail and self-motivationAbout the CompanyLatinum HR Solutions is a specialized recruitment and staffing firm serving the life sciences, pharmacovigilance, and healthcare sectors in India. The organization partners with leading global life sciences companies to connect qualified medical professionals with long-term, non-clinical career opportunities in drug safety, regulatory, and allied domains, maintaining a strong focus on quality, compliance, and professional growth.

Role & Responsibilities• Prepare, maintain, and track PSMF submission schedules to meet regulatory timelines• Develop and update regional Pharmacovigilance System Master Files (PSMFs) as per global and local PV regulations• Ensure accuracy, completeness, and compliance of all PSMF sections with SOPs, WIs, and regulatory updates• Manage PSMF document control including versioning, archiving, and change tracking• Develop and maintain Pharmacovigilance System Summaries• Coordinate with internal stakeholders across PV, Regulatory Affairs, and Business teams for data collection and validation• Liaise with affiliates and external partners to finalize PSMF documentation• Support development, review, and maintenance of SOPs related to PSMF activities• Assist during regulatory inspections, audits, and Health Authority queries related to PSMFQualification• Degree in Pharmacy, Life Sciences, Medicine, or related disciplineExperience• 2+ years of experience in Medical Writing with focus on PSMF and PV documentationSkills• Strong understanding of global pharmacovigilance regulations• Hands-on experience with EU GVP Module II (preferred)• Experience in SOP writing and document management systems• Excellent written communication and cross-functional coordination skills• High attention to detail with strong regulatory compliance mindsetAbout the Company• Alkem Laboratories is one of India’s leading multinational pharmaceutical companies

Role & Responsibilities• Prepare and review aggregate safety reports for global regulatory submissions including DSURs, PSURs, PADERs, RMPs, and Annual Reports• Lead report planning activities such as data collection, kick-off meetings, timelines, and comment resolution• Perform quality review of documents drafted by junior writers and provide constructive feedback• Develop ad-hoc safety reports, benefit–risk evaluation documents, and label update justifications• Write CTD summaries (clinical and non-clinical), clinical summaries, and regulatory documents• Draft adverse event narratives and medical information responses for healthcare professionals• Support signal detection activities and safety issue analysis reports• Conduct literature searches, define review strategies, and summarize findings• Collaborate with cross-functional teams and global clients to ensure timely, high-quality deliverables• Ensure compliance with ICH-GCP, pharmacovigilance regulations, and global regulatory requirementsQualification• B.Pharm / M.Pharm / Pharm.D• BSc / MSc (Life Sciences)• PhD (preferred)Experience• Minimum 2–3+ years of relevant pharmaceutical industry experience• At least 2 years of experience in medical writing or safety writingSkills• Strong expertise in pharmacovigilance and safety writing• Excellent written and spoken English communication skills• Knowledge of ICH guidelines, regulatory requirements, and PV practices• Strong organizational, time-management, and quality-focused approach• Proficiency in MS Office and regulatory documentationAbout the Company• Fortrea is a leading global CRO specializing in clinical development, pharmacovigilance, and regulatory services, Supports pharmaceutical, biotechnology, and medical device companies worldwide.

Role & Responsibilities• Conduct thorough medical reviews of patient data to identify potential safety risks associated with drugs• Develop and implement effective strategies for mitigating safety risks• Collaborate with cross-functional teams, including clinical development and regulatory affairs, to ensure safe drug development• Provide expert guidance on drug safety matters to internal stakeholders• Stay up-to-date with the latest developments in drug safety and apply this knowledge to improve patient outcomes• Participate in quality improvement initiatives to enhance the overall quality of patient careQualifications• 4-8 years of experience in Drug Safety or related fields• Medical degree with expertise in pharmacovigilance or drug safetySkills• Strong understanding of drug safety principles and regulations• Excellent analytical and problem-solving skills• Ability to interpret complex medical data and communicate findings effectively• Experience working with electronic health records (EHRs) and other healthcare software• Strong collaboration and communication skills• Ability to work independently and as part of a teamBenefits• Competitive salary and benefits package• Opportunities for professional developmentAbout The Company• Leading Client is a reputed pharmaceutical company known for its innovative approach to drug safety and patient care. The company emphasizes quality, safety, and patient-centric care, fostering an environment where experts collaborate to deliver high-impact solutions.

Role & Responsibilities• Determine the plan of action for incoming calls related to adverse events• Collect, process, and track incoming adverse and serious adverse events• Write safety narratives to document clinical events in the clinical trial process• Report on various safety data related to clinical trials and post-marketing surveillance• Collaborate with internal departments and investigative clinical research sites to ensure compliance with safety processesQualifications• Bachelor’s degree in Healthcare-related fields (Nursing, Pharmacy, Pharmacology, etc.)• Clinical experience or Clinical Research, case processing, and Post-marketing Pharmacovigilance experience is preferred• Proficiency in medical terminology and clinical safety proceduresSkills• Strong organizational and communication skills• Proficiency in English (written and spoken)• Proficient knowledge of Microsoft® Office• Broad knowledge of medical terminology• Ability to work collaboratively across teams• Strong attention to detail and ability to manage data accuratelyBenefits• Flexible work environment• Competitive compensation and benefits package• Competitive PTO (Paid Time Off) packages• Structured career paths with opportunities for professional growth• Company-sponsored employee appreciation events• Employee health and wellness initiativesAbout The Company• Medpace is a full-service clinical contract research organization (CRO), offering Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries.

Roles & Responsibilities: • Report safety information from India and India cluster (South Asia countries) to Global Safety • Follow up with reporters for additional safety information • Review and manage safety mailbox for incoming reports • Perform monthly reconciliation and compliance checks from a pharmacovigilance perspective • Prepare and submit Periodic Safety Update Reports (PSURs) to regulatory authorities as per regulations • Gather requirements and prepare regulatory dossiers for new products, clinical trials, variations, and renewals • Prepare responses to regulatory authority queries and coordinate with global teams • Support preparation for regulatory authority and expert committee meetings • Prepare and follow up on regulatory submissions for South Asia countries • Prepare and update product labeling materials • Review promotional materials for compliance with approved product registrations • Ensure timely updates to regulatory databases • Update and maintain local SOPs • Update and renew safety agreements with partners, manufacturers, and distributors • Coordinate price updates and ensure timely entry into NPPA pricing database • Manage lifecycle maintenance activities and update commercial teams on key milestones Qualifications: • Bachelor’s degree in Pharmacy, Life Sciences, Microbiology, Chemistry, or related field Experience: • Minimum 1+ year experience in India Regulatory Affairs and Pharmacovigilance • Experience within pharmaceutical or biotechnology industry preferred Skills: • Knowledge of Indian regulatory and pharmacovigilance requirements • Strong documentation and dossier preparation skills • Ability to coordinate with global and cross-functional teams • Good communication and regulatory compliance understanding • Attention to detail and ability to manage multiple submissions About the Organization: Ferring Therapeutics is a global, research-driven biopharmaceutical company committed to developing innovative treatments in areas of high unmet medical need. The company focuses on maintaining the highest standards of quality, regulatory compliance, and patient safety while delivering life-changing therapies worldwide.