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Global Safety Specialist
3 weeks ago
We are seeking a skilled Pharmacovigilance Advisor to join our team on a permanent full-time contract.
- The successful candidate will be responsible for ensuring compliance with quality systems and standards.
The key responsibilities include:
- Processing and reporting individual case safety reports (ICSRs) in a timely manner, maintaining global safety databases.
- Screening literature for ICSRs and safety information, conducting periodic case reconciliations.
- Drafting and finalizing pharmacovigilance activity reports (PVAs) and standardized data exchange agreements (SDEAs).
- Assisting with GVP inspection readiness activities, CAPA management, and non-conformances.
- Engaging in continuous improvement initiatives of the quality system.
The ideal candidate will have:
- A bachelor's degree in science, pharmacy, pharmacology, nursing, or a related discipline.
- A minimum of 2 years' experience in pharmacovigilance and quality management systems.
- Commercial awareness, ability to assess commercial implications of decisions.
- Awareness of pharmacovigilance legislation in Europe and the UK.
This role requires strong organizational skills, attention to detail, and excellent communication abilities. The successful candidate will be self-motivated, flexible, and able to work effectively in a team environment.
