Job Description: As a Drug Safety Physician (Position Code: DSP001), your primary responsibility will be the preparation of various reports, including Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Safety Update Reports (PSURs), Addendum to Clinical Overviews (ACOs), Addendum PSURs, PSUR Line Listings, and US Periodic Adverse Drug Experience Reports (PADERs), from aggregate data for products, in accordance with client conventions and requirements. Additionally, you will conduct quality checks of aggregate reports and perform signal detection-related analyses and reports, including cumulative analyses and issue event analyses. Your duties will also include the preparation and maintenance of Risk Management Plans (RMPs), interaction with clients to discuss potential signals and issues detected with products, and providing medical advice to drug safety scientists. You will maintain an excellent knowledge of the adverse event safety profile of assigned drugs, labeling documents, client guidelines, and Standard Operating Procedures (SOPs), ensuring compliance with internal and regulatory timelines for report submissions.
Minimum Qualifications:
Note: Ayurvedic, homeopathic, veterinary doctors, or professionals from other alternative medical streams and scientists with life sciences backgrounds need not apply for this position.
