Senior Pharmacovigilance Scientist
We are offering an exciting role as a Senior Pharmacovigilance Scientist- you will be an integral part of a biotechnology team based in Maidenhead. You will be serve as a product lead for Pharmacovigilance activities within the Safety function.
- Leads the signal management process for assigned product(s) and evaluates safety data and signals as part of ongoing pharmacovigilance activities.
- Manages literature review for safety information
- Collaborates with Global Safety Officers and other Safety MDs for assigned investigational programs including clinical trial activities (protocol review, ICF review, etc.)
- Leads process for responding to safety questions from regulatory authorities
- Contributes to and leads initiatives for process improvement and consistency regarding aggregate reporting, clinical trial safety oversight, signal management and responding to ad hoc safety questions
- Leads Aggregate Report management, including strategy, review and finalization of aggregate safety reports for assigned products, such as PSURs, DSURs, Pharmacovigilance Plans, Risk Evaluation and Mitigation Strategy Plans (REMS), and Risk Management Plans (RMPs).
Skills and Experience
- Minimum 7 years Pharmacovigilance experience, including experience in aggregate safety reports and safety signal management.
- Bachelor's Degree in biologic or natural science; or health care discipline
- Advanced degree (PhD, MPH, PharmD, etc.) required
- Understands, interprets, analyzes, and clearly presents scientific and medical data in verbal and written format.
- Applies clinical judgment to interpret case information
- Strong organizational skills, including the ability to prioritize independently with minimal supervision
- Basic knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects)
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Divya Mistry at 02038141315 or upload your resume on our website - www.proclinical.com/send-cv
A full job description is available on request.