Pharmacovigilance Consultant

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 are looking for

  • Excellent knowledge of the English language
  • Good relational and communicative skills
  • Good organisational, work planning and project management skills
  • Good knowledge of computer media

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.