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Pharmacovigilance Officer

Contract Type: Permanent
Location: Dublin
Contact Name: Laurentina Kennedy
Contact Email:

Job Description

Pharmacovigilance Officer Pharma Permanent

Our client, a major pharmaceutical company based in Dublin City wish to appoint an experienced Pharmacovigilance Officer (min 2 years’ experience) to join their team.
• Support the EEA QPPV to ensure that pharmacovigilance system is compliant with applicable EU regulatory requirements
• Update the Pharmacovigilance System Master File (PSMF)
• Update and oversee Safety Data Exchange Agreements (SDEA)
• Functionally oversee global national pharmacovigilance contact persons
• Provide input to PV training and evaluation standards
• Maintain awareness of local PV Regulatory requirements and implementation plans
• Support the QPPV on the validation status, validation failures, corrective actions and significant changes made in respect of the safety database
• Awareness, input and authority (where required) over the Risk Management Plan (RMP) and awareness of Marketing Authorisation (MA) conditions/obligations/commitments relating to
safety/safe use, including risk minimisation measures
• Oversight of on-going/completed clinical trials and other studies conducted by company or partners
• Awareness of relevant inbound safety-related information from  affiliates and contractual partners
• Author and implement procedures (at every level) relevant to the pharmacovigilance system and fulfilment of pharmacovigilance related commitments
• Update and implement the PV Quality Management System (QMS), including but not limited to, routine compliance metrics (PSUR/ICSRS), contributing to CAPA plans arising from pharmacovigilance-related audits and inspections and overseeing the quality of PV data
The ideal candidate must have Pharmacovigilance experience in the Pharmaceutical industry

For further information on this Pharmacovigilance Officer position please contact Laurentina Kennedy at The RFT Group on 01 2302400 / Check out all our open jobs on our Recruitment website:
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