Job Description:
Senior Pharmacovigilance Officer
Our client is currently looking to recruit a Senior Pharmacovigilance Officer, to be based in Waterford. This is a contract role, duration approx 12 months.
Specific Key Result Areas include:
· Ensure site responsibilities are met by acting as local drug safety officer (LSO) representative for the company
· Provide pharmacovigilance/drug safety support for all company product registered in Ireland
· Increase and maintain in-depth knowledge of drug safety issues relating to the Companies products
· Interact with company Global Pharmacovigilance Unit/EU QPPV and National Regulatory Authority to ensure local activities meet Global policies and National/EU requirements
· Adverse event case processing (post-marketing) and expedited reporting in accordance with local regulatory requirements
· Process and report Periodic Safety Update Reports in accordance with local regulatory requirements
· Provide training on Pharmacovigilance responsibilities relating to Adverse Events to all company personnel including relevant contractual third parties
· Identify trends and potential safety issues
· Periodic review of local Scientific and medical journals
· Ensure Safety Data Exchange Agreements are in place for all marketed products
· Communicate with Regulatory Affairs personnel, Medical Affairs, Sales and Marketing, Legal, local healthcare professionals and IMB on drug safety issues
· Lead Pharmacovigilance improvement projects (local/EU as required)
Requirements:
· Bachelors level degree in life or health sciences, pharmacy, nursing or comparable clinical research experience with 2+ years experience in post-marketing Pharmacovigilance/drug safety including reporting with the relevant bodies
· Experience and knowledge in Regulatory Affairs/Medical Information/Clinical practice is desirable
· In depth knowledge of cGMPs, cGPvP, Regulatory requirements and experience of Regulatory Inspections required
· 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
· Team player, committed, self-motivated and flexible
Please forward c.v's in the strictest of confidence to Martin O'Leary Brunel Recruitment on moleary@brunel.ie or call on 051-309652