Pharmacovigilance Specialist - Post-Market H/F Astek

Alsinova, the Astek Group subsidiary offering a complete CRO solution, is recruiting a Senior Preclinical Biostatistician for a project in the pharmaceutical sector.
Your mission (should you decide to accept it):

As part of the Drug Safety Department and under the supervision of the PV Manager, your mission will be to ensure that all pharmacovigilance activities related to marketed products are conducted in full compliance with regulatory requirements and internal procedures.

You will serve as a key contact for internal stakeholders and health authorities on post-market safety matters, helping ensure timely and accurate communication of safety information.

Your daily activities will be:

- Processing and evaluating Individual Case Safety Reports (ICSRs) from spontaneous, literature, and solicited sources
- Drafting and reviewing medical evaluations and narratives for serious and non-serious cases
- Assisting in signal detection and risk assessment, and supporting related decision-making
- Contributing to the writing and maintenance of Risk Management Plans (RMPs) and Periodic Safety Reports (PSURs, PBRERs, DSURs)
- Participating in audits and inspections, and implementing CAPAs as needed
- Ensuring regulatory compliance (GVP, EMA, FDA, ICH) and keeping procedures up to date
- Managing data entry and quality control in safety databases (e.g., Argus, ARISg, Veeva Vault Safety)
- Supporting communication with regulatory authorities and health professionals
- Collaborating with internal cross-functional teams (RA, QA, Clinical, Medical Affairs) and global safety teams

Your future team:

Join a collaborative and agile CRO environment where innovation, regulatory excellence, and scientific integrity drive every decision. You'll be supported by experienced colleagues, in a human-sized organization backed by the global reach of the Astek Group.