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Pharmacovigilance Career Profile
The Pharmacovigilance Officer (PVO) is responsible for the monitoring and reporting of adverse effects from company pharmaceutical products on the market. This information is supplied to the PVO by medical representatives, patients, doctors and other healthcare professionals in the field. It is the responsibility of the PVO to ensure that this data is suitably recorded, analysed and accurately processed while building strong collaborative relationships with medical affairs, commercial affairs and corporate (Global) pharmacovigilance (PV) functions. The PVO informed opinions will help the company maximise product safety and performance.
Typically the Pharmacovigilance Officer holds a degree in Pharmacology or a related life sciences field and about 3-5 years experience in clinical trials, regulatory or another medical affairs area. Typically graduates can secure entry-level PV associate positions in Contract Research Organization (CRO's) however it is difficult to secure entry level PV positions in pharmaceutical companies in Ireland.
Key Activities of the PVO
- Periodic Safety Update Reports (PSUR)
- Write and review Serious Adverse Effects (SAE) narratives and Council for International Organizations of Medical Sciences (CIOMS) forms for the pharmacovigilance department
- Signal detection (detection of early warning signs)
- Risk minimisation
- Safety exchange agreement
- To perform training for other departments as appropriate
- Clinical trial activities