Our client is currently seeking a Director/Senior Director, Pharmacovigilance Operations. This role is responsible for the oversight of the Pharmacovigilance (PV) Operations including oversight of PV safety vendor activities, overseeing interactions between pharmacovigilance and other internal departments, monitoring PV quality/compliance activities, and liaising with external partners for the contractual exchange of safety information. This position requires an experienced and accomplished safety operations professional who can provide functional and technical expertise while collaborating with multiple stakeholders.
Job Responsibilities and Duties include, but are not limited to, the following:
- Oversight of safety vendor activities including the case processing of adverse events in the global safety database for investigational & approved products; reconciliation of adverse event information with partners and other parties, and the production of a variety of safety reports
- Oversight of submissions of expedited reports to the FDA & other health authorities
- Develop standard procedures and guidelines for safety operations
- Participate in the creation of cross-functional Pharmacovigilance procedures
- Effectively utilize Key Performance Indicators and other metrics to assess compliance, productivity, opportunities for quality improvement, and to measure effectiveness of change initiatives
- Proactively lead case processing/ case quality improvement initiatives
- Fully support training of department personnel and other line functions involved in AE collection or processing such as Medical Affairs, sales, medical information, etc., in collaboration with the Quality organization
- Negotiate safety data exchange agreements and processes with business partners
- Provide support and subject matter expertise during audits and inspections
- Ensure readiness and management of FDA inspections
- Represent drug safety on project teams, other departments, and committees as needed
