A QPPV Medical Advisor is required to join a pharmaceutical company based in Buckinghamshire, UK.
As QPPV Medical Advisor you will provide support to the department in managing strategic functions of the QPPV office.
The main responsibilities of this QPPV Medical Advisor will include:
- Oversight of pharmacovigilance systems and business pharmacovigilance compliance.
- Management of the Detailed Description of Pharmacovigilance Systems (DDPS) for updating and variation applications.
- Review and commenting on EU-RMPs and FDA REMS.
- Support to Health Authority Inspections and internal audits for local operating companies and global systems.
- Support to functional teams for management of Health Authority queries.
- Oversight of PASS for EEA, with Health Authority approvals and follow up.
- Review and commenting on Health Authority proposals for changes in global pharmacovigilance regulations and guidelines.
- Oversight of Health Authority queries and commitments management and resolution.
- Back-up contact for QPPV Pharma.
- Assisting with pharmacovigilance processes and procedures.
The ideal candidate for this QPPV Medical Advisor job will hold the following qualifications, experience and skills:
- Medical degree and significant relevant clinical practice experience.
- Pharmaceutical medicine qualification, where available.
- 3 to 5 years pharmaceutical industry experience minimum, with some experience in pharmacovigilance.
- A sound knowledge of global pharmaceutical regulation, particularly for pharmacovigilance.
- Good communication skills, both verbal and written.
- Good computer skills (WORD, Email. Excel, PowerPoint).
- Ability to work in a team/matrix environment
For more information or to apply for the QPPV Medical Advisor job, please contact Ben Traies on 01438 743 047 or email firstname.lastname@example.org.