
Senior Pharmacovigilance Scientist
- Welwyn Garden City, Hertfordshire
- £29.85-48.00 per hour
- Permanent
- Full-time
- Use your pharmacovigilance expertise, particularly individual case safety report (ICSR) knowledge, to ensure safety data is processed and reported in a high quality, compliant manner, so it can be used to understand and communicate the product benefit risk to protect patients' safety.
- Performing oversight of service provider who execute ICSR tasks (and Medical Device reports)
- Identifying root causes of non-compliance to agree Corrective Actions and Preventative Actions (CAPAs), which you may be responsible for implementing
- Effective oversight of service providers via relationship management, and metrics and analysis.
- Leadership of complex initiatives with multiple stakeholders, with the ability to investigate and creatively solve problems and simplify, whilst meeting customer needs.
- Demonstrated experience in a breadth of areas pertaining to pharmacovigilance, and pharmacovigilance legislation; good knowledge of international regulations (ICH, EU GVP Modules, FDA) and an understanding of the pharmaceutical industry (product development and the commercial environment) and of rapidly-evolving personalised healthcare environment and ecosystem
- Medical Device processing experience, knowledge.
- Evidence of leading complex, time-pressured projects, working with a wide range of stakeholders.
- A relevant Life Science degree or equivalent experience in pharmacovigilance.
- Strong broad knowledge across end-to-end ICSR processes