Pharmacovigilance Manager

Job Title: Manager Pharmacovigilance

Department: Pharmacovigilance / Drug Safety
Reports to: Head of Pharmacovigilance
Location: Vadodara, Gujarat
Employment Type: Full-time

Job Summary

The manager, pharmacovigilance, is responsible for overseeing and managing in-house and outsourced pharmacovigilance (PV) activities to ensure compliance with global regulatory requirements. The role supports the Head of Pharmacovigilance in maintaining an effective pharmacovigilance system, ensuring high scientific quality, regulatory compliance, and timely delivery of safety outputs across the product lifecycle.

Key Roles and Responsibilities:

• Support the Head of Pharmacovigilance in developing, maintaining, and continuously improving the pharmacovigilance system in line with internal policies and global regulatory requirements.
• Ensure all PV activities comply with applicable regulations and guidelines, including ICH, FDA, EMA, EU-GVP, and other relevant health authority requirements.
• Develop, implement, and maintain Standard Operating Procedures (SOPs) related to pharmacovigilance activities.
• Ensure compliance of the PV system as documented in the Pharmacovigilance System Master File (PSMF) for both in-house and outsourced activities.
• Maintain monthly compliance processes and ensure adherence to quality, procedures, regulations, timelines, and consistency across all PV deliverables.
• Oversee the processing, evaluation, and reporting of adverse event (AE) reports, including serious and non-serious cases, in compliance with global regulations.
• Ensure timely and accurate submission of Individual Case Safety Reports (ICSRs) to regulatory authorities, ethics committees, and other stakeholders as required.
• Facilitate safety monitoring by optimizing scientific quality documentation and data entry of safety case reports, including spontaneous and litigation cases.
• Ensure timely submission of aggregate safety reports, including PSURs, PBRERs, and PADERs, in compliance with regulatory requirements and internal SOPs.
• Review and perform signal management activities in accordance with regulatory guidelines and SOPs.
• Ensure compliance of aggregate reports, signal management activities, and all EU-related PV activities.
• Assist in the identification, assessment, and management of risks related to drug safety.
• Collaborate with internal stakeholders (Regulatory, Clinical, Medical Affairs, Quality, etc.) to develop and implement Risk Management Plans (RMPs) and risk minimization measures.
• Provide oversight of outsourced PV activities and ensure vendor compliance with contractual and regulatory obligations.
• Responsible for partner and vendor audits related to pharmacovigilance activities.
• Maintain effective communication with external service providers to ensure high-quality deliverables.
• Act as a key point of contact with regulatory authorities, healthcare professionals, and internal stakeholders on safety-related matters.
• Ensure accurate and timely communication of safety information across all relevant parties.
• Manage and lead a team of pharmacovigilance professionals, ensuring efficient workflows and timely completion of tasks.
• Provide scientific and operational guidance to the PV team.
• Manage training activities for the PV team and other stakeholders to ensure ongoing regulatory compliance and safety awareness.
• Identify opportunities for team development and continuous skill enhancement in pharmacovigilance.
• Manage and maintain XEVMPD and SPOR databases with timely updates of safety variations in line with Article 57 requirements.
• Oversee reconciliation as per Safety Data Exchange Agreements (SDEAs).
• Ensure support on internal PV automation-related projects.

Qualifications & Experience:

Education

• Degree in Medicine, Pharmacy, Life Sciences, or a related discipline.
• An advanced degree (MPharm, PhD) is desirable.

Experience

• Minimum 8–10 years of experience in pharmacovigilance or drug safety, including leadership or managerial responsibilities.
• Strong experience in global case processing, aggregate reporting, signal management, and regulatory submissions.
• Experience managing vendors and outsourced PV activities.

Key Skills & Competencies

• In-depth knowledge of global pharmacovigilance regulations and guidelines.
• Strong leadership and people management skills.
• Excellent written and verbal communication skills.
• High level of attention to detail and quality.
• Ability to manage multiple priorities in a regulatory environment.
• Strong analytical and problem-solving skills.
• Proficiency in PV databases and safety systems.