Compass Life Sciences are partnered with a cutting edge CRO at the forefront of research across a wide variety of sectors and Pharma companies. With supported products varying from Covid-19 vaccines through to end-to-end PV support for Gene therapy, this is an incredibly exciting and diverse company with excellent prospects. Due to an ever-expanding portfolio and the increased general demand across the life science sector, our client is now actively seeking an EEA QPPV to support the current PV team and ensure compliance throughout all aspects of Pharmacovigilance.
- Having an overview of medicinal product safety profile and any emerging safety concerns
- Having awareness of any conditions or obligations adopted as part of the marketing authorisations and other commitments relating to safety or the safe use of the products.
- Having awareness of risk minimisation measures.
- Being aware of and having sufficient authority over the content of risk management plans.
- Having oversight of PV compliance metrics.
- Assisting with generation and maintenance of PV audit schedule.
- Input into due diligence activities for potential new acquisitions by clients.
- Liaise with local QPPVs/ local safety representatives as needed.
- Oversight and knowledge of all relevant SDEAs/ PVAs, with ability to request amendments as necessary.
- Being involved in the review and sign-off of protocols of post-authorisation safety studies conducted in the EU or pursuant to a risk management plan agreed in the EU.
- Having awareness of post-authorisation safety studies requested by a competent authority including the results of such studies.
- Have an awareness of any ongoing clinical trials.
- Ensuring conduct of pharmacovigilance and submission of all pharmacovigilance-related documents in accordance with the legal requirements and Good Pharmacovigilance Practices (GVP).
- Ensuring a full and prompt response to any request from the competent authorities in Members States and from the Agency for the provision of additional information necessary for the benefit-risk evaluation of a medicinal product.
- Providing any other information relevant to the benefit-risk evaluation to the competent authorities in Members States and the Agency.
- Providing input into the preparation of regulatory action in response to emerging safety concerns (e.g. variations, urgent safety restrictions, and communication to patients and healthcare professionals);
- Ensuring the necessary quality, including the correctness and completeness, of pharmacovigilance data submitted to the competent authorities in Members States and the Agency.
- Acting as a single pharmacovigilance contact point for the competent authorities in Member States and the Agency on a 24-hour basis and also as a contact point for pharmacovigilance inspections.
- Meet with the other EEA QPPV/Deputy EEA QPPVs on a regular basis, developing a consensus approach, working as a team.
- Expert understanding of all areas of pharmacovigilance
- A positive pragmatic outlook on all matters
- Strong communication skills
- Effective decision maker
- Able to delegate effectively
- Significant experience working in Pharmacovigilance
- Experience of both PM and CT is desirable
- Experience in novel therapies, cell therapy and gene therapy is desirable
This is role offers a fantastic opportunity to the right applicant, with great potential for development and promotion within an exciting company who are rapidly expanding across all Pharma sectors.
If you wish to apply, please contact David Jolley on +44 (0) 2393877358 or at [email protected]
Compass Associates Ltd. trading as Compass Life Sciences are acting as a Recruitment Consultancy for this permanent vacancy; we offer £200 worth of John Lewis Vouchers for each successful recommendation