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R&D Engineer
QA Manager
Dublin West
QA Manager
Market Access Manager
Dublin City Centre
Senior Chemist
Dublin North
Technical Sales Engineer
Republic of Ireland
Snr QA Specialist
Dublin South
QA Director
Dublin North
QA Manager Biologics
Dublin West
Principal Scientist
Dublin South
Program Manager
Snr Process Engineer
Dublin North
Qualified Person
Dublin West
QA Specialist
Dublin West
Head of Quality
Dublin West
Brian Christensen
Life Science

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Search Results for Pharmacovigilance
Job Title. Location Salary Actions

Pharmacovigilance Manager

Pharmacovigilance Manager Our client, a multinational pharmaceutical organisation requires a Pharmacovigilance Manager to join their team on a permanent basis. The Pharmacovigilance Manager will be Local Drug Safety Representative for all products registered in Ireland. The Pharmacovigilance Manager will maintain a compliant Pharmacovigilance function in Ireland. Responsibilities • Ensure compliance with all pharmacovigilance Global, European and Local SOPs and WI’s. • Act as local Pharmacovigilance representative for Regulatory bodies and for Pharmacov...

Location: Louth,
Pharmacovigilance Manager
Louth Not Disclosed

Drug Safety & Pharmacovigilance Senior Director

Our client is a Biopharma organisation with offices in Dublin. They are currently seeking a Senior Director, Drug Safety and Pharmacovigilance (DSPV) who will be a senior level employee serving also as Qualified Person for Pharmacovigilance (QPPV) in the EU. The successful person will be responsible for medical review of adverse event reports, aggregate safety reports and signal evaluation. The Senior Director DSPV will be a key member of the global drug safety and pharmacovigilance team, participating fully in pharmacovigilance activities, including medical review of advers...

Location: Dublin,
Drug Safety & Pharmacovigilance Senior Director
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