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.
• Provide medical input and/or review of aggregate reports including: PSUR, PBRER, PADER, Annual Reports, DSURs and ACOs.
• Conduct peer quality review of aggregate reports, and quality review of reports generated by the vendor.
• Support the PV Scientists in ensuring all aggregate reports are prepared, reviewed and submitted in line with regulatory requirements.
• Provide medical input to signal management activities for assigned products, ensuring signal detection is conducted in a regular, timely manner in accordance with schedule. This may include direct interaction with the Life Sphere Signal Management System, or the review of outputs generated from the system.