PV Physician - Medical Assessment

PV Physician: Lead medical oversight of pharmacovigilance activities, including benefit-risk assessment, signal detection, aggregate report review, risk management plans, regulatory responses, and safety documentation. Collaborate across functions to ensure patient safety, regulatory compliance, and accurate safety information throughout the product lifecycle.

Qualifications :

MBBS/MD with 5 years of experience in pharmacovigilance (ICSRs, Aggregate Reports or Signal Management) .

Responsibilities:

• Medical oversight including quality control of medical assessment of individual case safety reports (including coding, seriousness, expectedness, and company causality assessments) done by the vendor.
• Contribute to the scheduling of aggregate reports, RMPs and other safety related documents to ensure all required reports are documented on the report calendar. <...