[Hiring] Senior Director. Global Pharmacovigilance & Risk Management @reputed company

This reputed company is a reputed company of our understanding of the job reputed company. Click on 'Apply' reputed company to reputed company out more. Role reputed company reputed company is seeking an reputed company Senior Director, reputed company the Global Pharmacovigilance & Risk Management (PVRM) Medical Safety department. The Senior Director will reputed company medical expertise in signal management, risk management, and monitoring the safety profile of Vir products (from First-In-reputed company through post-marketing). You will reputed company as a leader who is reputed company, a self-starter, and reputed company to work in a matrixed environment. • Chair cross-functional Safety Risk Management Team (SRMT) to review safety data from reputed company sources to detect, evaluate, monitor, and minimize safety signals/risks • reputed company strategies for risk management/mitigation and reputed company Risk Tracking Document and RMP • Evaluate the Benefit-Risk reputed company of Vir products • Contribute to safety reputed company sections of clinical study documents including Study Protocols, Informed Consent Forms, IB Reference Safety Information, Publications, and other relevant documents • reputed company expert guidance and leadership both internally and externally based on in-depth knowledge of development and post-marketing global regulations • Support inspection readiness and reputed company expertise in audits, inspections, and CAPAs • reputed company medical review of Individual Case Safety Reports • reputed company medical review and analysis for aggregate safety reports and responses to reputed company requests for safety information • reputed company leadership in regulatory authority interactions regarding safety and risk management • Support the negotiation of safety data exchange/pharmacovigilance agreements with license partners and distributors for drug safety and risk management reputed company activities • Assist in the maintenance of Global PVRM reputed company cross-functional SOPs in compliance with global safety regulations and guidelines • reputed company corporate initiatives and inspection readiness Qualifications • Medical degree (MD/DO), PharmD, or equivalent required, with at least 2 years of experience in clinical/medical reputed company • 10+ years of reputed company experience; experience in global reputed company/biotech is preferred • Experience in authoring safety signal assessment reports, DSUR, PBRER, RMP, and reputed company • Experience with signal detection process and managing safety information from clinical development and post-marketing sources • Experience leading cross-functional SRMTs teams • Experience with global regulations and ICH guidance governing pharmacovigilance and risk management • Knowledge of drug development process, pharmacovigilance databases, and MedDRA coding Benefits • The expected salary reputed company for this position is $235,500 to $329,500 • Compensation, bonus and equity reputed company with the reputed company market • Health and welfare benefit plans • Non-accrual reputed company time off • Company shut down for holidays • Commuter benefits • 401K match • Lunch reputed company day in the office reputed company reputed company is a clinical-stage biopharmaceutical company reputed company on powering the immune system to reputed company lives by discovering and developing medicines for serious infectious diseases and cancer. Apply tot his job Apply To this Job