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Search Results for Pharmacovigilance
Job Title. Location Salary Actions

Director, PVE (Risk Management)

Our client is a global Bio-Pharma with a strong pipeline of products across a range of therapeutic areas from Infectious diseases, Inflammation & Oncology. They are seeking a Director of Pharmacovigilance & Epidemiology (Risk Management) to join a new team in Dublin. This team shall be a Centre of Excellence for global Paediatric clinical trials. The ideal person shall have a healthcare degree with a strong drug safety background. Role/Responsibilities: Signal detection and authorship of signal work-up documents in collaboration with a Medica...

Location: Dublin,
Director, PVE (Risk Management)
Dublin Not Disclosed

Associate Director, Pharmacovigilance & Epidemiology (PVE)

Associate Director, Pharmacovigilance & Epidemiology (PVE) Our client is a Global Biopharma who are establishing a new Centre of Excellence for Clinical Trials in Dublin. They are seeking an Associate Director who will manage Vendor Oversight Operations within PVE. Role/Responsibilities: Oversight of vendor(s) responsible for ICSR processing. This includes, but is not limited to: Scheduled and ad hoc meetings with the vendor(s) Oversight of training and quality metrics Review feedback and performance metrics relating to the vendor(s)f...

Location: Dublin,
Associate Director, Pharmacovigilance & Epidemiology (PVE)
Dublin Not Disclosed

Director, Pharmacovigilance Quality & Compliance (GVP)

Our client is a leading Global Biopharmaceutical organisation who play a crucial role in developing life-saving therapies. They are seeking a Pharmacovigilance Compliance Director who will join their Global R&D Quality and Compliance team. As a member of the global PV management team you will provide leadership in setting the strategic direction of Quality and Compliance PV activities. This role is suited to candidates who possess strong leadership skills and strategic thinking. Utilizing expert Good Pharmacovigilance (GVP) and Good Clinical Practice (GCP) knowledge. The su...

Location: Dublin,
Director, Pharmacovigilance Quality & Compliance (GVP)
Dublin Not Disclosed
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Pharmacovigilance Career Profile

Pharmacovigilance Officer

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