Pharmacovigilance (PV) Associate

What does a Pharmacovigilance (PV) Associate do?

As a Pharmacovigilance Associate you are part of the Pharmacovigilance Department (sometimes called the Drug Safety Department). Your role is one of reporting adverse effects (AEs) and side effects, in accordance with the current Dutch and European legislation for pharmacovigilance. You may also train colleagues in departments such as marketing and sales, medical and clinical on how they need to comply with their reporting responsibilities for drug safety. For example, when reporting AEs it is necessary to determine what an Individual Case Safety Report (ICSR) is and establish whether the ‘four elements’ of an identifiable patient, an identifiable reporter, a drug and a side effect are present during the triage-phase of a report on possible side effects. You report to your company headquarters on clinical study-related AEs and SAEs and those arising from products already on the market and any other pharmacovigilance / product safety issues. A Pharmacovigilance Associate (PVA) role may also be called a Pharmacovigilance Officer, Drug Safety Officer (DSO), Drug Safety Associate, or a Patient Safety Specialist.

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What roles and responsibilities can you expect as a Pharmacovigilance (PV) Associate?

As a PV Associate you are supporting the administrative aspects of drug safety reports, especially adverse event (AE) information, and entering data from clinical trials. You ensure that reporting and assessment is complete and complies with current practices.

In summary, typical roles and responsibilities include the following:

• ensuring the rapid and timely processing and managing of new and follow-up reports of adverse events (AEs) and side effects, as well as serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSARs);
• reporting AEs and side effects to the EMA, the Dutch authorities and – if these arise from clinical trials – to ethics committees and Drug Safety Management Boards (DSMBs), and steering committees of the respective clinical trials;
• processing all the AEs, SAEs and SUSARs in the Global Safety Database according to the applicable company policies and Standard Operating Procedures (SOPs), and as required by the Dutch and European Authority for reporting adverse events;
• contacting those who reported the AEs and side effects to obtain complete information for analysis;
• ensuring that assessments are carried out according to AE, SAE and SUSAR criteria and forwarding eventual AEs/SAEs and SUSARs to the head office;
• contributing to keep local processes, procedures and systems up to date and assisting with, and participating in, audits and inspections when these arise.

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What education and skills do you need as a Pharmacovigilance (PV) Associate?

Starting out as a PV Associate, you will need to have completed a bachelor or master’s degree in a biomedical or biopharmaceutical field. On top of this, personal skills required include:

• excellent computer skills;
• good communication and writing skills in Dutch and English;
• a sound knowledge of medical terminology.

What salary can you expect as a Pharmacovigilance (PV) Associate?

The salary of a Pharmacovigilance Associate varies according to your experience and the responsibilities of the job in question. Your starting salary in the Netherlands is likely to be between €33.000,- and €48.000,- per annum.

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