Wayne, PA 6m ++ contract
Under the oversight of the PVRM TA Head, the PVRM Medical Lead is responsible for ensuring development and execution of risk management strategies, appropriate medical safety assessments and surveillance, compliant regulatory authority reporting, and communication of safety information for assigned Global products.
Responsibilities
• Oversee investigational and postmarketing regulatory reporting and pharmacovigilance activities for assigned Global products
• Lead the development and execution of risk management strategies and author internal risk tracking plans and risk management/pharmacovigilance plans for submission to global health authorities for assigned products
• Medically review individual case safety reports from all sources for assigned products.
• Oversee, prepare, and review Periodic/Annual Reports (FDA) and Periodic Safety Update Reports and other Benefit/Risk Update Reports (FDA and Global Regulatory Authorities)
• Oversee, prepare, and review responses to ad hoc regulatory queries, and signaling topic reports
• Assist the VP in developing and maintaining state-of-the-art pharmacovigilance processes and procedures within Shire R&D, and as part of the Global PV & RM organization.
• Lead pharmacovigilance activities as a member of drug development project teams; co-lead Safety Review Teams
• Lead safety-labeling activities for assigned products
• Support the Qualified Person for Pharmacovigilance in the EEA relative to issues related to assigned products