Pharmacovigilance- Safety Physician

Purpose

The PV Physician is primarily responsible for performing medical review of individual case safety reports (ICSRs), Aggregate Reports (ARs) and review of safety sections of RSIs, validation of global Literature ICSRs and performing initial activities of signal detection.

Key Responsibilities

• To do medical review of (clinical and spontaneous), including coding, seriousness, expectedness, and company causality assessments

• Perform quality review of aggregate reports including medical review of aggregate reports including: PSUR, PBRER, PADER, Annual Reports, DSURs, and ACOs.

• Review and provide safety input of commercial, marketing and Medical enquires as required.

• Oversight and medical inputs for global literature monitoring activities. • Provide medical input to reference safety information, Investigator Brochures, product labels and patient information leaflets to ensure the most up to date and accurate safety information is present in all labeling information.

• Develop SOP and procedural document for medical activities. Cross Functional Connect

• Working within PV team and cross-functionally with key stakeholder functions including Clinical, Regulatory Affairs, Medical Affairs, Commercial Teams and Business Units

• Interactions with service providers for PV activities