We are recruiting for a Pharmacovigilance Scientist to join an established Pharmaceutical company in Hertfordshire, UK.
As Pharmacovigilance Scientist, you will participate in the day-to-day functioning of the drug safety department with a major involvement in the preparation of Aggregated Safety Reports. In addition, they will become therapeutic specialists and provide scientific review and input on documents and signal generation processes.
- Support the Local Safety Officer, the Regional Safety Officer and General Safety Officers in their functions.
- Be able to triage in-coming PV reports in accordance to their seriousness and regulatory context.
- Perform follow-up activities for PV Reports
- Participate in the expeditious reporting of PV Reports to regulatory authorities.
- Act as a product specialist and aid in the scientific review of documents, including but not exclusive, Investigational Brochures, final study reports and protocols
- Participate as a key member in signal generation process.
- Provide support to the PV Physicians in the evaluation of PV Reports.
- Provide QC of PV Reports to ensure correct and accurate input of source data onto the global safety database (ARISg).
- Perform SAE reconciliation.
- Have major involvement in the production of Aggregated Safety Reports.
- Prepare Business Objects searches / listings for aggregated Safety Reports and ad hoc safety requests.
- Ensure that such activities are performed to high standards of quality and timeliness in line with the best industry standards.
- Prepare and review SOP’s and Working Practices.
- Compliance to SOP’s, processes, practices and guidelines and aiming towards excellence.
Qualifications and Experience:
- The candidate should be a life science or nursing graduate preferably with proven experience in a Global / European Pharmacovigilance / Clinical Safety department.
- Experience with global safety databases, MedDRA coding and E2B reporting.
- Experience in scientific review of documents is required.
For more information, or to apply for this Pharmacovigilance Scientist position, please contact Hendre Moolman at CK Science on +44 (0)1438 743047 or email me a email@example.com quoting 20830 to indicate your interest.