Lead effective vendor management strategies for PV.
Ensure PV department inspection ready.
Responsible for PV functional service provider (FSP) strategy and managing the selection process.
Responsible for developing a PV database strategy.
Provide Pharmacovigilance Operational support to clinical trial study teams and commercial products.
Serve as a subject matter expert for internal audits and global regulatory inspections.
Serves as key point of contact between PV and the CROs regarding PV operation management.
Communicates regularly with CROs and develops quality ICSR case processing and reporting metrics.
In conjunction with the compliance team, supports the escalation and investigation of safety and non-compliance issues and identifies root causes for late ICSR submissions and the implementation of appropriate corrective actions, as needed.
Develop PV training plans and competency assessments for PV department.
Contributes to the development and maintenance of Safety Management Plans (SMPs).
Provides oversight and direction to direct report(s).

Bachelor's degree in scientific related field preferred or combination education/experience
10+ years of PV experience in the pharmaceutical/biotech industry
Clinical trial product support and commercial product support experience preferred
Proven track record of leadership and operational excellence.
Ability to help shape key department goals and objectives, drive process and operational efficiencies, and contribute to ongoing development of innovative best practices both internally and with other cross-functional groups.
Able to work independently, establish work priorities, and execute decisions with minimal guidance.
Experienced in global regulatory requirements for pharmacovigilance
Direct experience participating in regulatory authority inspections

Director of Safety Operations – Pharmacovigilance

Key skills