Role: Pharmacovigilance Processes and Training Manager
Duration: 8 months
Pay rate: up to £450/day
Start Date: ASAP
Our Maidenhead based client is currently looking for an experience Pharmacovigilance Processes and Training Manager to join them for maternity cover on initial contract until the end of this year.
Key responsibilities will include:
- Define and support implementation and improvement of PV processes in accordance with GVPs, FDA and international PV legislation including the preparation of corresponding PV Standard Operating Procedures/ Work Instructions/conventions documents and associated training materials in close collaboration with the EU QPPV/local QPPVs and the relevant subject matter expert/department director
- Ensure alignment of PV documentation with both regulatory requirements, internal policy as well as quality manuals
- Ensure improvement and updating of PV and PV related processes and procedures as required by CAPAs, new regulatory requirements and regulations
- Maintaining track of all controlled documents relevant to PV activities
- Act as a lead contributor for allocated sections of the PSMF Core and its Annexes to ensure compliance of the PV System
- Prepare and maintain PV training matrix for employees, support training of conventions in close collaboration with Head of PV Ops and relevant subject matter experts, support the preparation of PV training materials and ensure that the relevant training is assigned to PV staff, and other stakeholders as appropriate
- Ensure appropriate PV training documentation is in place.
- Strong communicator with excellent English language skills, both written and spoken, ideally demonstrable experience in a medical/scientific writing.
- Good networking and team skills for successful cooperation with internal and external customers
- Excellent negotiation, conflict resolution, decision making, problem solving, and presentation skills
If this role sounds of interest and you require further information then please respond with an up to date copy of your CV for consideration.