Manager - PV Physician - Healthcare - MBBS

Key Responsibilities:

- To do medical review of (clinical and spontaneous), including coding, seriousness, expectedness, and company causality assessments. Providing/reviewing medical review comments for ICSRs.

- Perform quality medical review of aggregate reports including: PSUR, PBRER, PADER, Annual Reports, DSURs, and ACOs. Monitoring B/R analysis of products.

- Safety Document Review for Studies: Provide medical/safety input to other cross-functional documents, including clinical study protocols, study CRF, coding review, final study reports, dossier documents and other documents required to support filing activities. Participation in product/project team meetings.

- Performing/monitoring Signal Detection activity for products and RMP/REMS development.

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

- 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.

- Developing/reviewing Health Hazard Assessment Reports.

- Develop SOP and procedural document for medical activities.

- Providing medical support to QPPV and PVOIs. Act as Deputy to Global QPPV.

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

Desired Skills & Competencies:

- Good working knowledge of PV regulations including FDA, EU & local requirements.

- Strong data analysis and report writing skills

- Excellent teamwork and interpersonal skills

- Strong problem solving and decision making skills