An exciting biotechnology company is looking for a Pharmacovigilance Scientist to join their talented team in Berkshire. If you're interested in changing the face of medicine, then this might be the company for you.
- Collaborates on the preparation and authoring of aggregate safety reports for assigned products.
- Conducts literature review for safety information and interacts with other groups to obtain necessary data (i.e., Epidemiology, SAE data).
- Collaborates with Clinical Trial Physicians and Global Safety Officers on assigned investigational programs including protocol review, safety committee management, data analysis, signal detection, ad hoc requests and other product activities, as assigned.
- In collaboration with Sr. PV Scientist / AD, coordinates and authors responses to safety questions from regulatory authorities for assigned products.
- Contributes to initiatives for process improvement and consistency regarding aggregate reporting, clinical trial safety oversight, signal management and responding to ad hoc safety questions.
Skills and Experience
- Minimum 5 years industry experience, with a minimum of 3 years of PV experience.
- Bachelor's Degree in biologic or natural science; or health care discipline
- Advanced degree (PhD, MPH, NP, PharmD, etc.) preferred
- Understands, interprets, analyzes, and clearly presents scientific and medical data in verbal and written format (including intermediate understanding and application of medical concepts and terminology).
- Interacts collaboratively and effectively in a team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as with external colleagues
- Applies clinical judgment to interpret case information.
- Basic knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects). Knowledge of common safety database systems.
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.