Posted on Mar 15, 2019 by Tina Dunne
Role & Responsibilities:
You will be responsible for the management and review and analysis of aggregate safety data for company product portfolio.
Liaising with Regulatory Agencies (RA) / review of RA feedback on case quality and compliance issues.
Review, advise and approve relevant local and global guidelines, policies, Internal Procedures and SOPs across companies.
Review/input into post-authorisation safety study protocols and study reports at local and global level.
3rd level Biological/life Sciences Degree or equivalent
3-5 years experience in similar role within the pharmaceutical industry.
Experience working with safety databases
Experience writing large safety reports e.g., DSURs, PADERs, PSURs, PRBRERs, RMPs is desirable
Pharmacovigilance practice and procedure
EU Competent Authorities and Regulations
Marketing Authorisation rules and regulations
For full details contact Tina 1 or email your CV in confidence to