Senior Director, EU-QPPV & Head of PV Operations in Munich, Germany
Samuel Whyley-Smith at CK Group is recruiting for a Senior Director, EU-QPPV & Head of Pharmacovigilance Operations to join a Clinical Stage Biopharmaceutical Company based in Munich, Germany on a permanent basis.
Our client is focused on the development of novel therapeutic compounds to treat distinct diseases where there are currently limitations of existing treatment options or in order to provide a treatment option where there currently is none. With their lead product candidate having already shown clinically meaningful activity for two distinct conditions they are now planning a key hire in the Clinical Drug Safety team at Senior Director level.
The Senior Director is a key member of the Pharmacovigilance team and is responsible for global PV operations, drug safety systems and leadership of European safety activities including interface with EU Regulatory Authorities, as well as being responsible for global PV compliance and the PV quality system, whilst fulfilling the duties as an EU-QPPV.
Responsibilities will include:
- Fulfil the QPPV legal requirements and oversee global PV reporting compliance, PV quality assurance, the postmarketing signal management process and related safety systems.
- Implement changes to standard procedures and ensure that processes and their documentation are fit for purpose.
- Maintain PV inspection readiness with respect to records, procedures and systems. Lead corrective actions in response to inspection findings.
- Oversee PV services vendors, and participate in search and selection activity.
- Lead the production and maintenance of the PSMF, EU-RMP and safety sections of the SPC.
- Maintain compliance with EudraVigilance industry user requirements.
- Collaborate with the VP, European Medical Affairs to ensure that post-authorisation safety studies are delivered to time and quality.
- Review and approve the PBRER.
- Recruit, supervise and develop PV Operations team members.- Member of the medical governance committee.
- Support the European leadership team with PV expertise.
- Ensure that PV/safety data exchange agreements are created and maintained with business partners.
- Supervise or oversee the UK QPPV.
- Act as deputy for the VP, Safety & Pharmacovigilance.
As the Senior Director you will have the following qualifications, skills and experience:
- MD or PhD with at least 12 years of industry pharmacovigilance experience required, including PV operations leadership.
- Thorough knowledge of GVP, ICH and EMA guidelines on PV is required.
- Prior EU QPPV/deputy QPPV experience is an advantage.
- Drug safety systems management experience is an advantage.
- Comfortable working independently with minimal supervision.
- Strong management capabilities with a proven record as a functional leader.
- Highly organized, results driven, problem solver with a global outlook.
- Superior written and oral communication skills in English and German, and the ability to work with different levels of management.
- Extensive knowledge of MedDRA and PV databases.
- Highly motivated with the ability to be flexible in a fast-paced environment.
- EudraVigilance EVDAS/XEVMPD training is an advantage.
- Regional and international travel will be required: up to 20%.
Full job description is available upon request.
For more information or to apply for this position, please contact Sam Whyley-Smith on 01246 580040 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 45721 in all correspondence.