20 days ago
Pharmacovigilance Case Workflow Manager
(Permanent - Full time - Dublin)
As a Pharmacovigilance Case Workflow Manager you will be responsible for provide both line and operational management of the case processing team as well as ensure all ICSR procedures are aligned global standards and regulations.
- Manage the receipt, processing, follow-up and reporting of ICSRs to ensure compliance with company procedures and regulations
- Establish and monitor Key Performance Indicators (KPIs) for each staff member and ensure that annual reviews take place according to company policies
- Raise deviations for non-compliance to case processing SOPs, regulations or guidelines and implement Corrective and Preventive Actions (CAPAs) where required
- Liaising with Regulatory Agencies on case quality and compliance issues
- Maintain up to date awareness of worldwide Regulatory Intelligence in respect of case processing and ensuring adequate SOPs, work instructions or data entry specifications exist that reflect the same
- Creation and maintenance of safety reporting plans by collating reporting requirements globally and oversight of implementation of the same in the Global Safety Database (GSD)
- Review, advise and approve relevant local and global guidelines, policies, Internal Procedures and SOPs
- Review/input into post-authorisation safety study protocols and study reports at local and global level
- To review AE listings to identify data issues and safety trends as required
- Lead initiatives to develop, implement and conduct appropriate training in all aspects of Pharmacovigilance activities by liaising with the PV manager
- Prepare for audits/inspections as required
- Participation in ICSR team meetings as well as attending regular PV management meetings
- Third Level Degree in Science or a relevant discipline
- Minimum of 3 years' experience in the Pharmaceutical industry with working knowledge of Global Pharmacovigilance regulatory requirements for ICSRs
- Knowledge and experience with clinical protocols and clinical study reports
- Familiarity with MedDRA coding dictionary
- Proven leadership experience
The next step for you:
Should this position be of interest to you please forward your CV to Renata Kormann from Next Generation Recruitment or alternatively call on the main line on +353 1 6629120.
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