PV Senior Specialist
- Posted 09 September 2022
- LocationCambridge
- Job type Contract
- Discipline Medical & Drug Safety
- Reference66612
- Contact NameDominic Pritchard
Job description
6 month Senior PV Specialist Contract - Remote based
BioTalent are working with an innovative Biotech company in the golden triangle of the industry. The PV specialist will be part of a remote (UK and US) based team to fulfill EU post marketing activities to a very high standard.
Offer:
6 month contract
Attractive pay rate + IR35 uplift
Remote working
Responsibilities:
- Responsibility and hands PV Operations
- Drafting, preparing, reviewing, maintaining the PSMF to an inspection ready state
- Coordinating activities internal and external to the organisation
- PV activities e.g. reconciliation, audits, med info queries, liaising with QPPV, raising deviations, follow/update SOPs, work complianctly to EU legislation
Requirements:
- Bachelor's degree or higher
- 3+ years PV activities in EU post authorisation environment
- PSMF hands on experience
- Thorough knowledge of ICH, US, EU safety reporting regulations and guidelines
If you match the above criteria please be in touch with Dom on 0203 8286059 or dominic.pritchard@biotalent.com