UNIT: Pharmacovigilance
We are looking for a Pharmacovigilance Consultant to be included in the Pharmacovigilance Unit of JSB Solutions. The ideal candidate has a degree in scientific disciplines (Pharmaceutical Chemistry and Technology, Pharmacy, Medicine, Biotechnology) and, preferably, a Master in Pharmacovigilance and at least two years of experience in the field of Pharmacovigilance.
What we will do together
We will manage all aspects of PV both in pre-marketing and post marketing and in particular we will manage the following activities:
- Preparation and maintenance of the Pharmacovigilance System Master File (PSMF)
- Drafting and updating of Standard Operating Procedures and Operating Instructions
- Collection, management and evaluation of adverse events/suspected adverse reactions received from each source
- Drafting of pharmacovigilance agreements with third parties (SDEA, PVA, SMP)
- Monitoring of medical-scientific literature (local and international)
- Drafting of the Risk Management Plan (RMP) and implementation of risk minimization measures
- Management of Eudravigilance: XEVMPD and ICSR
- Preparation and notification of periodic safety reports to Competent Authorities such as PBRER, PSUR, DSUR
- Implementation of a signal management system (Signal detection – EVDAS)
- Using the PV Database
- Support for audit or inspection preparation and management
What we have in common
Reliability, accordance, respect, care, curiosity, courage, perseverance and passion are the values that represent us. If you have these values in common with us, send your application.
