As a Pharmacovigilance Associate / Drug Safety Officer you will support the Pharmacovigilance Department (or Drug Safety Department) in fulfilling the obligations for reporting side effects within the current Dutch and European legislation for pharmacovigilance / drug safety. You will also train colleagues in the marketing and sales departments, as well as medical and clinical departments on compliance with their reporting responsibilities for Drug Safety. Furthermore you will communicate with your companies headquarters on PV/DS matters, both spontaneous marketed drug related (unsolicited) AE’s and SAE’s but also clinical study related events. One of the fundamental principles of reporting adverse events is determining what an Individual Case Safety Report (ICSR) is. During the triage-phase of a report on possible side effects, it is important to determine whether the “four elements” of a valid ICSR are present: (1) an identifiable patient, (2) an identifiable reporter, (3) a drug, and (4) a side effect. Synonyms for the Pharmacovigilance Associate (PVA) are Drug Safety Officer (DSO) and Patient Safety Specialist.
Some tasks/responsibilities of a Pharmacovigilance Associate:
- Taking care of rapid and timely processing of new and follow-up reports of adverse events and side effects (Adverse Events, or AE’s), as well as Serious Adverse Events (SAE’s) and Suspected Unexpected Serious Adverse Reactions (SUSAR’s) which are unexpected SAE’s with (possible) causality to the (study) drug, both from spontaneous reports (out of the market) and out of clinical drug research;
- Processing all the AE’s, SAE’s and SUSAR’s in the Global Safety Database according to the applicable Company Policies and Standard Operating Procedures (SOP’s), and as required by the Dutch and European Authority for reporting adverse events;
- Partly responsible for timely reporting the adverse events and site effects to the EMA, the Dutch authorities and, in the event that the adverse events and site effects arise from clinical trials, to ethics committees and / or Drug Safety Management Boards (DSMB’s) and / or Steering Committees of respective clinical trials;
- Contacting reporters of the adverse events and site effects to obtain complete information for analysis;
- Ensuring that product complaints are assessed according to AE, SAE and SUSAR criteria and forwarding eventual (S)AE’s and SUSAR’s to the head office;
- Contributing to keep local processes, procedures and systems up to date for recording and processing of side effects;
- Assisting with the preparation of the audit/inspection and participating in the audit/inspection when appropriate;
- Ensuring that all the required documents from reporting adverse events and aggregated reports (SLL, PSUR / PBEBR, DSUR, RM planning & reporting) are managed.
Your background and profile:
- Completed Bachelor or Master education in a (bio) medical or biopharmaceutical direction;
- Excellent computer skills;
- Good writing skills in Dutch and English;
- Knowledge of medical terminology;
- Good communication skills in Dutch and English.
Terms of employment and salary
The salary of a Pharmacovigilance Associate is extremely variable, mainly depending on experience and scope of responsibility. Your starting salary is between € 32.000,- and € 40.000,- per year.
Interested in a position as a Pharmacovigilance Associate?
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