Pharmacovigilance Assistant Reporting to the Head of Pharmacovigilance based in Martigny.
Publication date:28 September 2022
Place of work:Rue du Levant 146, 1920 Martigny
Debiopharm is a private, Swiss-based biopharmaceutical company. Mainly focused in oncology and bacterial infections, the company develops innovative therapies that target high unmet medical needs with an ambition to improve patient quality of life. Debiopharm Research & Manufacturing S.A., based in Martigny, is a pharmaceutical research, development and production facility, inspected and registered with the main regulatory authorities. The Company is a world leader in polylactic-co-glycolic acid (PLGA)-based injectable, sustained-release technology.
To strengthen its « Pharmacovigilance » Organization, Debiopharm Research & Manufacturing in Martigny is looking for a
Your Responsibilites :
- Triage and process of Individual Case Safety Reports (ICSR) according to Safety Data Exchange Agreements (SDEA) with Debiopharm commercial partners.
- Assist in maintaining SDEAs.
- Check the appropriate implementation of the SDEAs and relative documents.
- Ensure exchanges of information with our commercial partners in line with established timelines.
- Provide with KPIs in order to monitor SDEAs compliance.
- Ensure reconciliation of case reports with commercial partners.
- Update and maintain data in the Safety Database for our commercial products.
- Archive of safety information such as case reports and safety correspondence.
- Track ICSRs.
- Summarize KPIs and generate CAPAs for unmet/delayed KPIs.
- Assist with the management of the Pharmacovigilance System Master File.
- Create and maintain quality documents.
- Provide general administrative support.
Your Profile :
- Commercial diploma (CFC) or equivalent.
- First experience in supporting a Pharmacovigilance department within the Pharmaceutical or/and Medical Devices Industry.
- First Experience in working with a Safety Database.
- Ability to manage multiple and varied tasks and prioritize workload with attention to detail.
- You are a Team-player, ready to support your colleague.
- Excellent interpersonal, written and verbal communication skills.
- Fluent in speaking and writing both in English and French.