Clinical Safety Officer
CK QLS are recruiting for a Clinical Safety Officer to join a global biopharmaceutical company at their site based in Lausanne on a contract basis for 6 months, with the possibility of extension. This role is looking for somebody to start as soon as possible.
Location: This Clinical Safety Officer position will be based at our clients site picturesque location in Lausanne.
Clinical Safety Officer Role: The responsibilities of this role will include:
- Managing case processing for clinical trials and electronic reporting to EMA.
- Ensuring oversight of our PV vendor.
- Performing QC for SAEs and reports SUSARs to EMA using the Eudravigilance system.
- Managing interactions with internal departments as well as vendors, commercial partners and CROs.
- Coordinating Development Safety Update Reports (DSURs) and writes Safety Management Plans.
- Performing QC for SAEs and reports SUSARs to EMA using the Eudravigilance system.
Your Background:
- Life Science graduate, or equivalent nursing or medical degree level or equivalent in a relevant discipline.
- Previous experience within clinical safety is essential.
- Previous experience working in the conduct of clinical trials and safety management in clinical trials in pharmaceutical industry of CROs.
- A good knowledge of EU and US regulations are desired.
- Strong communication skills and attention to detail.
Apply: For more information or to apply for this Clinical Safety Officer role, please contact Jocelyn on 0041 (0) 782 516 595 or email jblackham@ckqls.ch, quoting job ref 48480.
Please send all of your correspondence in English.
It is essential that applicants hold entitlement to work in Switzerland.
