PV Physician - Medical Assessment

PV Physician is primarily responsible for the oversight of and provision of medical input to benefit-risk assessment activities including: ad hoc data analysis in support of internal/external queries preparation and review of aggregate reports signal detection and evaluation support of benefit-risk evaluation efforts generation and/or review of risk management plans (RMPs), risk evaluation and mitigation strategies (REMS), identification of risk minimization measures handling of responses to Regulatory Authority queries, scientific/medical input to other safety related documentation including Health Hazard Evaluations, clinical study protocols, final study reports, dossier documents, Medical Affairs activities, commercial/marketing information, as needed and providing support for product labelling activities.

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. Assess and validate identified signals and ensure appropriate actions are taken for confirmed signals. Summarize findings and present to the Head of Medical Assessment, Regional PV Heads and Head of Global Pharmacovigilance at appropriate forums.

• Conduct aggregate safety data review on an ad hoc basis to support benefit-risk evaluations.

• Provide medical input to RMPs and REMS activities as required and review RMPs authored by PV Scientists.

• Prepare and/or review Health Hazard Evaluations and other ad hoc safety reports as requested.

• Contribute to the identification and design of additional risk minimization measures and support their implementation in collaboration with PV Scientists, local affiliates and third- party partners.

• Clinical & Regulatory Activities: Provide medical/safety input to other cross-functional਍ocuments, including clinical study protocols, study CRF, statistical analysis plan (SAP), coding review, final study reports, dossier documents and other documents required to support filing activities. Participation in product/project team meetings

• Provide safety input, advice and support to commercial, marketing and Medical Affairs activities as required.

• Labelling document review: 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 labelling information.

• Regulatory Authority query management: liaise with Regulatory Affairs to respond to PV- related Regulatory Authority queries coordinate with various stakeholders when finalizing the response, ensure responses are tracked to closure.

• Participate in due diligence activities for product acquisitions/divestments as required.

• Participate in development of CAPA and take ownership of CAPA completion where assigned.

• Participate in regular, scheduled meetings with PV team/service provider/third parties as required.

• Support for PV QMS: Support the development and revision of department SOPs and work instructions. And participate in the review of cross-functional SOPs which include reference to PV activities.

• Support PV training for new members of PV team and non-PV personnel, particularly product- specific, scientific and medical training.

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