Pharmacovigilance Officer
CK QLS are recruiting for a Pharmacovigilance Officer to join a global biopharmaceutical company at their site based in Lausanne on a on a contract basis for 6 months, with the possibility of extension. This role is looking for somebody to start as soon as possible, ideally before the end of March.
Company:
This company is a family run organisation, developing medicines for unmet medical needs.
Location:
This Pharmacovigilance Officer position will be based at our clients site picturesque location in Lausanne.
The responsibilities of this role will include:
- Ensuring the regular update of the safety database: e-TMF filing for on-going studies and also previous studies & transfer of SAE data from a CRO safety database to Safety database.
- Ensuring the processing of SAEs according to the SOPs and study specific Safety Monitoring Plan.
- Coordinating Development Safety Update Reports (DSURs) and writing Safety Management Plans.
- 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.
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.
- 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 Pharmacovigilance Officer role, please contact Jocelyn on 0041 (0) 782 516 595 or email jblackham@ckqls.ch, quoting job ref 47849.
Please send all of your correspondence in English.
It is essential that applicants hold entitlement to work in the country where the services will be delivered.
