Senior Clinical Safety Officer
Jocelyn Blackham is recruiting for a Senior Clinical Safety Officer to join a growing biopharmaceutical company, heavily focused on oncology and anti-infectives. This role is offered on a 12 month contract.
The main purpose of the role will be to:- Manage case processing for clinical trials and electronic reporting to Health Authorities
- Manage the interactions with internal departments as well as vendors, sponsors, commercial partners and CROs in the area of Clinical Safety and Pharmacovigilance
- Ensures reconciliation between the clinical and safety database
Further responsibilities will include:
- Coordinating Development Safety Update Reports (DSURs), Safety Management Plans, and reviews Periodic Safety Update Reports (PSURs), Risk-Management Plans (RMPs)
- Ensuring Signal detection activities for products in development as a member of the Safety Assessment Committee
- Ensuring the appropriate filing of clinical safety documents in the eTMF
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Degree in Biology, Pharmacist
- Previous experience in clinical safety with good knowledge of EU and US regulations
- XEVMPD and Eudravigilance training certificates would be an asset
- Experience in Oncology drug development preferred
This is an excellent opportunity to join an independent biopharmaceutical organisation collaborating with global players.
For more information or to apply for this position, please contact Jocelyn Blackham on 0041 (0) 800 106 106 or email firstname.lastname@example.org. Please could you send any correspondence in English. Please quote reference 51640 in all correspondence.