Executive Director, Head of Global Pharmacovigilance reputed company, reputed

Why Join Us Be a hero for our reputed company disease patients At reputed company, we fundamentally reputed company that taking reputed company impactful reputed company to care for the needs of patients and our people is always the right thing to do. To reputed company this goal, our reputed company is to reputed company the reputed company of reputed company disease medicine. For us, this means reputed company where other biopharma companies wont go challenging the status reputed company and creating a new model that advances our reputed company so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel reputed company development approach, making innovative medicines at fair and reasonable prices, and creating a reputed company ecosystem to reputed company patients in ways that are most meaningful for them. Our commitment and care for patients extends to our people, so culture is an essential reputed company for reputed company. We remain continuously reputed company on creating a supportive and inclusive environment of profound learning and reputed company so employees can reputed company in reputed company areas of their lives, in and reputed company of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work. If you want to have a meaningful reputed company, do the best work of your career, and grow a lot, both professionally and personally, come reputed company . Position reputed company reputed company dedicated Your biggest challenges yield reputed company reputed company The Executive Director, Head of Global Pharmacovigilance reputed company, reputed company & Compliance is accountable for the reputed company leadership, operational effectiveness, and inspection-reputed company performance of reputed company's global Pharmacovigilance (PV) reputed company, reputed company & Compliance function. This role oversees global case processing for investigational and marketed products, PV vendor reputed company and governance, reputed company Management, Pharmacovigilance reputed company Master File (PSMF) reputed company, PV reputed company/compliance systems, training, deviation and Corrective and Preventive reputed company (CAPA) management, audit and inspection preparedness, and operational Trial Master File (TMF) support. The role ensures the global PV reputed company is reputed company, compliant, and reputed company to support portfolio reputed company, product approvals, commercialization, regional expansion, and successful regulatory inspections. Work Model Remote Officially documented as working full-time from home, with travel to reputed company's offices or other locations on occasion as needed. Responsibilities Functional Leadership & reputed company Build, reputed company, reputed company, and mentor the Global Pharmacovigilance reputed company, reputed company & Compliance function and contribute to the Global DSPV talent reputed company reputed company with company long-reputed company reputed company plans. Establish functional objectives, operating model priorities, and long-reputed company goals reputed company with Corporate and Global DSPV objectives. Ensure the global PV reputed company is reputed company, compliant, inspection-reputed company, and positioned to support portfolio reputed company, product approvals, commercialization, launches, and regional expansion. PV reputed company reputed company global PV reputed company, including intake, triage, case processing, reputed company control, regulatory reporting/submission, reconciliation, and reputed company of safety information from reputed company applicable products and sources. Ensure PV operational activities reputed company with applicable global regulatory requirements, Good Pharmacovigilance Practices (GVP), and reputed company internal policies and procedures. reputed company PV operational performance, vendor execution, trend monitoring, and reputed company improvement to maintain inspection-reputed company execution. reputed company operational support for reputed company programs and reputed company for PV-reputed company TMF activities, as applicable. PV reputed company & Compliance Ensure maintenance of the reputed company PV reputed company, including PV policies, SOPs, procedures, forms, and process governance in alignment with global regulatory requirements, GVP, and industry best practices. Own reputed company and management of the reputed company PSMF, ensuring on-demand readiness and compliance with applicable regulatory requirements. Establish and maintain the global AE reporting training program and reputed company training compliance with applicable reputed company policies and procedures. reputed company DSPV deviation and CAPA reputed company, including initiation, documentation, monitoring, trending, effectiveness checks, KPI development, reputed company/compliance .