Europe QPPV London
Permanent / London, UK
Circa £80,000 pa
Our client is a rapidly expanding generics business that has doubled in size twice in the last 3 years. The speed of the growth has opened up countless opportunities for progression and development including opening up an opportunity for an experience QPPV to join the business.
You will have oversight of the PV systems in terms of structure and performance, case processing and medical review including QC and QA procedures.
The EU QPPV will perform the following activities on behalf of the Marketing Authorization Holder.
Responsibilities will include:
- Oversight of the PV system.
- Acts as a main PV contact point for the regulatory authorities and the European Medicine Agency
- Ensure that the Marketing Authorization Holder has appropriate PV system in place.
- Oversees functioning of PV systems in all relevant aspects including its quality systems including
- Contractual arrangements,
- Database operations,
- Compliance data regarding quality,
- Audit/inspection reports
- Ensuring that all PV processes conducted throughout the EU are in accordance with pertinent regulations
- Oversees preparation and maintenance of PV System Master File
- Maintains an overview of safety profiles and any emerging safety concerns of all Marketing Authorization Holder products
- Review and sign off of Risk Management Plans.
- Ensures that the signal management process is in place in order to identify possible safety signals on Marketing Authorization Holder products
- Ensures that the risk based audit of PV system is performed at pre-defined intervals
You will need to have experience in Pharmacovigilance at a senior level and also have experience in a QPPV role.
If you have difficulty in applying, have any questions or you cannot find what you are looking for please contact us on 0044 (0) 207 421 0000 or email
We regard all communication and correspondence as confidential. Full job descriptions are available on request.