Senior Manager Clinical Pharmacovigilance and
2 weeks ago
CK Group are recruiting for a Senior Manager Clinical Trial Pharmacovigilance and Pharmacovigilance Operations to join a pharmaceutical company on a 12-month contract. This role is remote.
**The Role**:
The main purpose of the role will be to
- Contribute to the development, implementation and successful oversight of the PV vendor to ensure fulfilment of internal standards and global regulatory requirements
- Manage wider departmental operational activities including ownership and development of specific operational procedures
- Review and provide input into study-related documents (e.g., trial protocols) and safety aspects of other trial documents
**Further responsibilities will include**:
- Directing the planning, preparation, writing and review of safety portions of DSURs including coordination of data requests
- Developing and implementing with PVG head, key performance indicators for PVG vendor activities
- Maintaining tracking system for various safety related activities including KPIs for internal and externally managed processes, aggregate report schedules and aspects of PV regulatory intelligence.
**Your Background**:
To succeed in this role, you will come from a life science background, with strong direct pharmacovigilance experience
- Expert knowledge specifically in managing the pharmacovigilance of products in development / in clinical trials
- Ability to manage Individual Case Safety Reports (ICSRs) including narrative writing (preferred)
- Experience of working with vendors, CROs and relationship management.
**Apply**:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 54368 in all correspondence.
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