A global biotech based in Cambridge is looking for an Pharmacovigilance (PV) Compliance Assistant Manager to join their team on a permanent basis. In this role you will be responsible for ensuring PV compliance across all marketed products and clinical trials.
- Ensure the quality, accuracy and reliability of Safety data during case processing and timeliness of Regulatory submissions
- Creation and review of all PV metrics and following up on non-compliances to through to resolution
- Oversight of Quality metrics, ensuring that non-compliances are escalated and documented appropriately
- Oversight of PV audits
- Oversight of PV CAPAs through to closure
- PSMF management (including liaising with cross-functional departments to gain the appropriate PSMF data)
- PSMF process management
- PV training of PV staff and role specific training outside of the department
- Oversight and maintenance of all PV contracts and Agreements
I you have experience in Pharmacovigilance and PV Compliance or CAPAs and are looking at joining a global biotech at an exciting stage, don't hesitate to apply!
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales