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Senior Manager Clinical Pharmacovigilance and Pharmacovigilance Operations

Remote, Orkney Isles   •  £0 - £70 per hour  •  Contract/Temporary, Full time


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.


You must have the right to work in the UK. Learn more

  • Agency: CK Group
  • Reference: 54368
  • Posted: 5th September 2022
  • Expires: 3rd October 2022

CK Group

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