Associate Manager - Pharmacovigilance

The Associate Manager - Pharmacovigilance will support global drug safety operations by ensuring timely processing, evaluation, and reporting of adverse events in compliance with international regulatory requirements. The role involves managing pharmacovigilance activities, maintaining safety databases, and collaborating with cross-functional global teams to ensure patient safety and regulatory compliance.

Responsibilities:

- Manage and oversee pharmacovigilance case processing and adverse event reporting.

- Ensure compliance with global regulatory guidelines including ICH, GVP, and applicable health authority requirements.

- Review and validate Individual Case Safety Reports (ICSRs) for accuracy and completeness.

- Coordinate signal detection, risk management, and safety monitoring activities.

- Support preparation and submission of safety reports such as PSURs, DSURs, and aggregate reports.

- Collaborate with clinical operations, regulatory affairs, and medical teams for safety data evaluation.

- Train and mentor junior pharmacovigilance professionals.

- Support process improvements and automation initiatives within pharmacovigilance operations.

Skills

- Strong knowledge of pharmacovigilance processes and drug safety regulations.

- Experience with safety databases such as Argus Safety, ArisG, or similar systems.

- Understanding of MedDRA coding and case processing workflows.

- Knowledge of ICH guidelines, GVP, and global regulatory requirements.

- Strong analytical, documentation, and reporting skills.

Experience: 6-10 Years