Pharmacovigilance Associate

D_ebiopharm 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

**Pharmacovigilance Associate, 100%**

**Your Mission**:
The Pharmacovigilance Associate is responsible for assisting the Head of Pharmacovigilance in various post marketing safety activities for Debiopharm marketed products, in compliance with international and local regulations and with Standard Operating Procedures (SOPs). This role includes an emphasis on the maximization of efficiency and effectiveness of pharmacovigilance processes to ensure a proper functioning of the overall pharmacovigilance system.

**Your Responsibilities**:

- Manage the exchange of Individual Case Safety Reports (ICSRs) among Debiopharm business partners
- Performs reconciliation of ICSRs exchange
- Processes Swiss ICSRs and reports them to health authorities
- Generates various quality documents (KPIs, CAPAs, etc )
- Monitors the Swiss local literature
- Assists in the maintenance of Safety Data Exchange Agreements (SDEAs) with business partners
- Assists in the maintenance of SOPs and other procedural documents
- Assist in the preparation and review of various reports (aggregate reports, risk management plans, signal detection reports, etc )
- Assists in the maintenance of the Pharmacovigilance System Master Files (PSMFs)
- Participates in audits and inspections
- Participates in various meetings with business partners and the EU QPPV
- Other tasks assigned by management

**Requirements**:
**Your Profile**:

- Degree in a life science-related field (biology, pharmacy, biochemistry, chemistry, etc )
- At least 2 years of experience in pharmacovigilance
- Knowledge of European Good Pharmacovigilance Practices (EU GVP) and Swiss regulatory requirements
- High degree of initiative and ability to work with mínimal supervision
- You are a Team-player, ready to support your colleagues, with strong writing and communication skills
- Fluent in speaking and writing both in English and French.