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.
This company is a family run organisation, developing medicines for unmet medical needs.
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.
- 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.
For more information or to apply for this Pharmacovigilance Officer role, please contact Jocelyn on 0041 (0) 782 516 595 or email email@example.com, 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.