Director PV Operations - EMEA
Hendre Moolman at CK Clinical is recruiting for a Director of Pharmacovigilance Operations to join a global pharmaceutical company at their site based in Hertfordshire on a permanent basis.
Your main responsibilities in this role will be to: Lead and manage the EMEA based pharmacovigilance team responsible for pharmacovigilance activities within the region including:
- Regional case processing and submission
- Alliance management
- Compliance and quality assurance activities
- Training and oversight of affiliate network of safety offices
- Leading the EMEA Pharmacovigilance Operations team, its ongoing projects, processes and staff
- Leading the implementation of procedures at regional level which ensure the quality, regulatory compliance and cost-effectiveness of PV activities delivered under the EMEA office
- Ensuring regional implementation of and maintenance of Business Partner/SDE specific PV process requirements
- Building and maintaing close working relationships with PV peers and other EMEA functions (e.g. - Regulatory and Medical Affairs) and affiliate safety groups to ensure the development and maintenance of effective collaborations
- Ensuring PV requirements for collection and reporting of safety information for non-interventional studies, and patient support programmes are met in the EMEA region
You are required to have the following qualifications, skills and experience:
- A life science, pharmacy or nursing qualification and proven success in a senior pharmacovigilance role
- Extensive experience within pharmacovigilance and a consistent record of strong contribution, in addition to success in tackling new challenges and responsibilities
- In depth knowledge and understanding of safety regulations for both marketed and investigational products
- Experience in planning, and managing multiple projects in a matrix or cross-functional environment
- Previous line management experience is desirable
- Experience of working across countries and cultures will be an advantage
If you are employed by this client you will be joining a global pharmaceutical company based in Hertfordshire. Other benefits include:
- Company car allowance
- Company bonus
For more information or to apply for this Director of Pharmacovigilance Operations position please contact Hendre Moolman on +44 (0)1438 842 970 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now.
CK Clinical 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 CL31805 in all correspondence.