Medical Director, Pharmacovigilance
Are you a Pharmacovigilance / Drug Safety focussed Medical professional with EU QPPV experience? Our client - one of the world’s largest and leading CROs - is looking to fill their exciting Medical Director of Pharmacovigilance position based in Reading, or at various locations in Germany.
The key to the success of an applicant for this fantastic opportunity will lie in their ability to demonstrate a combination of Medical experience within industry, alongside a specialised commercial background of Pharmacovigilance or Drug Safety. Candidates from a CRO or consultancy background are preferred, but all applicants with relevant experience are welcome.
- Medically qualified professional (M.D. / MBBS Etc.)
- Past QPPV experience (CRO/Consultancy experience preferable but not essential)
- Post marketing PV experience
- Proven input to Signal Detection plans
- An understanding and ability to formulate Risk Management Plans
- Knowledge of Safety reporting requirements and processes
- Past responsibility of the Medical Reviews of ICSR
- Experience working as a Medical professional working in a hospital setting
- Previous positions may include: Associate Director of Pharmacovigilance, Director of Pharmacovigilance, Head of Pharmacovigilance, and Medical Director Etc.
- General responsibilities associated with EU QPPV position
- Review and approve the Pharmacovigilance Trial Master file (PSMF)
- Ensure compliance and timely submission of Individual Case Safety Reports (ICSR)
- Review Periodic Benefit Risk Evaluation Reports (PBER)
- Review Period Safety Upgrade Reports (PSUR)
- Review and give input for signal detection plans and activities
- Provide input for European Risk Management Plan (EU-RMP)
- Provide input to Investigator Brochure (IB) and Summary of Product Characteristics (SmPC)
- Provide oversight for Product Information, Labelling and Safety Variations
- Have a direct role in the review and sign off of protocols for post-authorisation safety studies in the EU
- Act as the single point of contact for Pharmacovigilance for the competent authorities and for pharmacovigilance inspections
- Line management responsibility
- An innovative, highly established and respected CRO providing clinical services to the Pharmaceutical and Biotechnology Markets
- A solid history of successful worldwide Drug Development with numerous successful marketed drugs over varied therapy areas
- In order to secure the services of the best talent in the sector, our client is willing to be flexible on package.
- Salary will be commensurate with experience.
Zest is working to a strict deadline on this position, so please apply now and your application will be reviewed immediately.
Contact: Jason Cox
Telephone: 0114 229 1672