Description
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
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 minimal 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.
