Director, Head of PV Operations
- Provide leadership to the PV operations team inclusive of mentoring, support, and career growth of team members.
- Working with cross-functional team members to ensure efficient and compliant safety data collection from clinical trials and post-marketing surveillance.
- Working with the Senior Vice President and Head Drug Safety and Pharmacovigilance, provides support and oversight of pharmacovigilance service vendors.
- Assist in production and review of safety sections of GCP documents (e.g. investigators’ brochure, informed consent forms).
- Assist in safety review, aggregate reporting and data reconciliation.
- Supervises the search and retrieval of safety data from safety and clinical trial databases for inclusion in external and internal reports.
- Supervises the contributions of PV Operations to periodic safety and clinical study reports and final case narratives.
- Supervises the quality review of cases processed by external vendor.
- Partner with clinical QA in GCP and GVP inspection readiness.
- Representing Safety & PV on study teams.
- Work with clinical operations colleagues to provide safety-related communication to investigational sites and ethics committees.
- Work with quality assurance colleagues to correct PV compliance issues.
- Support REMS operation activities.
- Prepare for surveillance activity after commercial launch and support sales force.
- Support safety database configuration, maintenance and system enhancement working with the PV Database Strategy and Analytics team.
- Healthcare or life sciences degree.
- 8-10 years prior experience in pharmacovigilance.
- Experience with clinical and commercial lifecycle phases is desirable.
- Comfortable working independently with supervision.
- Knowledge of pharmacovigilance regulations and guidelines.
- Demonstrated understanding of safety database, medical literature and electronic data capture technology.
- Highly organized, results driven, problem solver.
- Superior written and oral communication skills and the ability to work with different levels of management in several departments.
- Highly motivated with the ability to be flexible in a fast-paced environment.
- Up to 20% travel expected.
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