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Details

Pharmacovigilance Manager


Reference:ASDK-886161 Location: Louth
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed

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 Pharmacovigilance inspections conducted in Ireland
• Stay up to date on Local and European safety regulations while advising Global and European Pharmacovigilance of any changes to Local regulations
• Liaise with all relevant bodies in relation to Pharmacovigilance and drug safety issues including Regulatory Affairs, local healthcare professionals, and EU QPPV
• Ensure highest level of data privacy and confidentiality is maintained
• Ensure Pharmacovigilance out-of-hours service provision and absence backup plans in place.
• Update Local and Global tracking systems on a regular basis
• Maintain relevant and accurate records and documentation of all processes and procedures that are subject to audit
• Oversee local pharmacovigilance budget control and planning
• Maintain a Local Business Contingency Plan for pharmacovigilance activities
• Participate in European projects and Working groups organised by Global Patient Safety or European Pharmacovigilance Management
• Participate in the Global and European Pharmacovigilance meetings
• Act as line manager for Deputy Local Drug Safety Representative
• Ensure direct reports are given the coaching and support required to perform their duties to agreed standards of performance in line with Company Performance Management System

Requirements
• BSc in life or health sciences, pharmacy, nursing or comparable
clinical research experience with 3+ years’ experience in post-marketing Pharmacovigilance and drug safety including reporting with the relevant bodies
• Demonstrable experience of working successfully under pressure and in a rapidly changing environment
• Excellent knowledge of Regulations and sources of regulatory information
• Excellent knowledge of Global Pharmacovigilance policies and procedures
• Experience with documentation compliance
• In-depth knowledge of GVPs, EU/National Regulatory requirements and experience of Regulatory Inspections
• Project Management
• Auditing experience/skills
• Team player, committed, self-motivated and flexible
• Excellent oral and written presentation skills, computer proficient with exceptional attention to detail
• Highly organised with ability to successfully prioritise and work on multiple tasks



If you would like further Information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252