Manager - Pharmacovigilance
OR
Last updated on 08 Dec 2025
Overview
A Manager in Pharmacovigilance oversees the monitoring and evaluation of adverse drug reactions to ensure patient safety and regulatory compliance. This role is crucial in minimizing risks associated with pharmaceutical products. They act as a bridge between clinical development, regulatory authorities, and healthcare professionals. The position demands expertise in drug safety regulations and global reporting standards. It also involves leading a team and developing strategies for effective pharmacovigilance systems.
Job Description
- Lead and manage the pharmacovigilance team responsible for monitoring and reporting adverse drug reactions.
- Ensure timely collection, evaluation, and documentation of safety data in accordance with global regulatory requirements.
- Collaborate with cross-functional teams including medical affairs, regulatory, and clinical research to align safety strategies.
- Oversee periodic safety update reports (PSURs), risk management plans, and other regulatory submissions.
- Develop and implement SOPs, training modules, and quality control measures related to pharmacovigilance processes.
- Liaise with regulatory bodies during audits and inspections, ensuring full compliance and preparedness.
- Continuously evaluate the benefit-risk profile of marketed and investigational products to guide decision-making.
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