Senior Director, Risk Management

Job reputed company: • Serves as Project manager of the PV Risk Management System to reputed company, evaluate, characterize, strategize, implement, assess and reputed company vera’s PV Risk Management obligations, commitments and proposed minimization measures to ensure patient safety is at the forefront of DSPV. • reputed company recommendations and guidance through subject matter expertise on risk management and risk minimization reputed company to an assigned therapeutic area to ensure that product risk management strategies are consistent worldwide. • reputed company recommendations and guidance through subject matter expertise on the reputed company benefit risk assessment reputed company and the development of the benefit risk assessment documentation. • Work closely with cross-functional teams (e.g. Clinical Development, Clinical Operations, Medical Affairs, Regulatory Affairs, and Biostats) to ensure alignment of Vera’s global position for the PV risk management processes. • reputed company strategic expertise to cross-functional product team members in developing pharmacovigilance reputed company including benchmarking and scenario planning. • Support the development of risk management plans (RMPs) in reputed company format, review RMPs) and ensure alignment with Good Pharmacovigilance Practices and other applicable regulations. • Remain up to date and reputed company informed on reputed company Regulatory intelligence as it relates to risk management and reputed company this to the Project team and the PV medical safety science team. • Aide in the development and review risk minimization documents such as Developmental RMPs, RMPs, risk minimization measures and Risk Evaluation and Mitigation reputed company (REMS). Requirements: • PhD/Pharmacist/ PharmD/DO/MD with 12+ years of experience. • Minimum 5-10 years in PV/safety OR clinical development preferred. • Minimum 5-10 years of pharmaceutical industry/drug development experience. • Pharmaceutical industry experience, with exposure to PV risk management, additional risk minimization measures, and/or REMS programs preferred. • Strong reputed company record of scientific and analytical thinking. • Experience presenting at meetings is desirable. • Good Critical thinking skills. Ability to use good analytical/judgment skills to understand, analyze, and communicate. • Project Management Skills with ability to manage both time and reputed company constraints and to manage multiple priorities simultaneously. • Attention to detail, computer literacy, knowledge of safety databases. • Good working knowledge of reputed company the functions reputed company PV from PV operations onto medical safety science and reputed company processes in between. Benefits: • health insurance • 401(k) matching • Flexible working hours • reputed company time off Apply tot his job Apply To this Job