Senior Director, Pharmacovigilance Operations Specialist
4 weeks ago
We are seeking a highly skilled and experienced Pharmacovigilance Operations Specialist to join our team at GlaxoSmithKline. The successful candidate will be responsible for overseeing vendor oversight of case processing and related activities, ensuring adherence and compliance to GSK processes and contracted tasks.
Key Responsibilities- Oversee vendor oversight of case processing and related activities
- Ensure adherence and compliance to GSK processes and contracted tasks
- Contribute to investigations into non-compliance and perform gap analysis
- Critically analyze data and metrics produced by the vendor
- Manage the GSK ICSR Management team and ensure all ICSR management activities are appropriately resourced
- Escalate any resourcing issues and provide strategic advice to the function
- Degree in life sciences or medically related field or previous experience equating to educational requirements
- Case processing experience in clinical trials and post-marketing
- Experience in quality processes for PV including compilation of compliance metrics, writing deviations / quality issue reports
- Experience in performing trend analysis, gap analysis, and SOP writing
- Knowledge and experience with pharmacovigilance systems
- Proven experience developing and delivering high-quality training
- Proven experience in line management
- Experience of escalation mechanisms
At GlaxoSmithKline, we are committed to creating a workplace where everyone feels welcome, valued, and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment.
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