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 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.
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.
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 54368 in all correspondence.
You must have the right to work in the UK. Learn more
- Agency: CK Group
- Reference: 54368
Website: CK Group
- Posted: 5th September 2022
- Expires: 3rd October 2022