Drug Safety Specialist
SIRE Group
- Amsterdam, Noord-Holland
- Vast
- Voltijds
Our client is one of the top multinational pharmaceutical companies in the world whose purpose is to build a healthier, more resilient world. Turning the impossible into the possible by discovering, developing, and delivering medicines and vaccines for millions of people around the world.Role Description
Your role as a Drug Safety Specialist is to execute PV activities in compliance with local legislation and company guidelines. You’ll play a vital role in fostering a strong understanding of PV within the company, contributing to maintaining excellent customer relations, and actively collaborating with the North Europe Cluster PV team.Responsibilities
- Acquire and maintain comprehensive knowledge of company procedures and legal requirements related to Pharmacovigilance.
- Handle Individual Case Safety Reports (ICSRs) according to local regulations and company Quality Documents (QDs).
- Provide pertinent safety information to Health Authorities (HA), internal stakeholders, and external parties, ensuring appropriate involvement of relevant departments.
- Support local safety surveillance activities, risk management, and product alert programs, while informing relevant authorities as per regulations.
- Participate in the development and updating of local/MCO Quality Documents (QDs) in alignment with corporate standards and local laws.
- Degree in Life Sciences (e.g., Pharmacy, Medicine, Biomedical, or equivalent).
- Previous work experience in the pharmaceutical industry, preferably in pharmacovigilance or related areas.
- Fluent in Dutch and English, both written and spoken.
If you think this role is for you and you want to explore more of the possibilities, please contact Leri Salve Lapore and apply via the button below.