Senior Manager, Pharmacovigilance (Deputy QPPV)
About the role
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Senior Pharmacovigilance Manager (Deputy QPPV)
- QPPV qualifications to lead PV projects.
- Project management- managing client projects, including managing client relationships and project budgets.
- Review, quality control, and submissions of Individual Case Safety Reports (ICSR’s) to clients/ client partners and/or regulatory agencies.
- Preparing ICSR files for 3rd party review including adjudication and review by Drug Safety Monitoring Boards.
- Conducting audits or gap analysis of client pharmacovigilance systems including regulatory agency inspections and client and internal audits.
- Providing training in pharmacovigilance legislation, regulations and industry best practices to colleagues and clients.
- B.Sc. or advanced degree in in Health Sciences or registered nurse or equivalent relevant experience and training.
- Extensive experience working within a pharmacovigilance environment including knowledge of ICH, EEA Good Pharmacovigilance Practices (GVP), European legislation and regulatory guidance
- Excellent project management skills are required, as is the ability to effectively manage multiple simultaneous projects.
- Strong people skills, ability to manage people, time and resources while developing a supportive team environment
- The ability to interact with clients, to adapt to their priorities, and while providing strategic direction is essential.
- Strong command of the English language coupled with fluency in local language.
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