Copy of 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 s...