Officer

Candidate should have working experience in Bulk drug & API Plant. Should aware warehouse functions Like RM/PM Receipt, Issuance, Storage & Departmental documentation Pharmacovigilance: Monitor and analyze adverse events, side effects, and safety data related to pharmaceutical products, medical devices, and biologics. Adverse Event Reporting: Collect, evaluate, and report adverse event data to regulatory authorities in compliance with applicable regulations and guidelines. Risk Assessment: Assess the potential risks and benefits of drug products and provide recommendations to minimize risks while maximizing therapeutic benefits. Signal Detection: Identify potential safety concerns through signal detection methodologies and data analysis. Safety Documentation: Prepare and maintain safety-related documentation, including Risk Evaluation and Mitigation Strategies (REMS) and Periodic Safety Update Reports (PSURs). Regulatory Compliance: Ensure compliance with international and regional pharmacovigilance regulations, guidelines, and reporting requirements.