Pharmacoviligance Manager

Job Listing No: 9740000

Pharmacoviligance Manager

Dundalk, Co Louth – Overview of the Pharmacovigilance Manager: Act as Local Drug Safety Representative (LSO) for all the sites products registered in Ireland. Maintain a compliant Pharmacovigilance function in Ireland Key Responsibilities: Ensuring compliance with all pharmacovigilance Global, European and Local SOPs and WI’s. Act as local representative for Pharmacovigilance for Health Products, Regulatory Authority (HPRA) and for any PV inspections conducted in Ireland. Be up to date on all Local and European safety regulations, advising Global and European Pharmacovigilance of any changes to Local regulations in a timely manner. Liaise with all relevant bodies in relation to PhV / drug safety issues including Regulatory Affairs, local healthcare professionals, EU QPPV. Ensure highest level of data privacy and confidentiality is maintained. Ensure out-of-hours PhV service provision and absence backup plans in place. Updating Local and Global tracking systems on a regular basis. Maintain re… – Permanent – Full-time

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