Director of Pharmacovigilance Operations
2 days ago
Job Summary
">The Senior Director, Pharmacovigilance Operations will lead the overall PV operations, encompassing adverse event collection, processing, and reporting from various sources. The role involves vendor management, PV quality management, and ensuring regulatory compliance across the entire portfolio in clinical development and post-approval phases.
">Key Responsibilities
">* Develops and implements PV system strategies, processes, and vendor deployments to ensure operational excellence.
">* Oversees PV operational aspects for the entire portfolio, including ICSR collection, processing, reconciliation, and reporting, along with associated quality and training activities.
">* Facilitates communication with internal functions, external vendors, and license partners involved in receiving, investigating, or reporting AEs.
">Requirements
">* Health care degree (RN, Pharm D) or PhD in biomedical or pharmaceutical sciences, with extensive drug safety experience highly desirable.
">* Minimum 15 years of PV operations experience within the biotechnology or pharmaceutical industry, including 5 years in a management position with direct reports overseeing business process outsourcing vendors and relationships.
">* Expert knowledge of global PV requirements, including US Code of Federal regulations, European Union guidelines on good pharmacovigilance practices, and ICH guidelines.
">About Aveo Pharmaceuticals Inc
">Aveo Pharmaceuticals Inc is a commercial-stage, oncology-focused biopharmaceutical company dedicated to delivering innovative medicines that improve patient lives.
">We strive to create an environment of diversity, equity, and inclusion, fostering a culture that values representation and innovation.
">Join our team and contribute to shaping the future of cancer treatment.
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