Director, ICSR Management Team - Job ID: 2018
Ascendis Pharma
The apply link worked recently (not employer-confirmed).
Role summary
Ascendis Pharma seeks a Director to lead the ICSR Management Team within Global Patient Safety Operations. The role encompasses team leadership, oversight of case safety report processing workflows, vendor management, and ensuring regulatory compliance with pharmacovigilance guidelines. The Director will serve as a subject matter expert on individual case safety reporting and collaborate with senior leadership on strategic safety initiatives.
What they're looking for
- Pharmacovigilance regulatory and guideline expertise, particularly ICSR processing
- Team leadership and people management experience with budget oversight
- Knowledge of ICH-GCP guidelines, Health Authority regulations, and safety database operations
- Subject matter expertise in Individual Case Safety Reports and adverse event processing
- Experience with vendor management and quality assurance in regulated environments
- Demonstrated ability to develop SOPs and training documentation for GxP compliance
What you'll be doing
- Oversee ICSR Management team leadership, including budget, headcount, and organizational development
- Ensure all safety reports are processed in safety database and reported per ICH-GCP and regulatory requirements
- Monitor pharmacovigilance vendor performance, conduct quality checks, and provide operational guidance
- Coordinate follow-up activities for missing safety information and perform root cause and CAPA analyses
- Maintain regulatory compliance, identify processing deviations, and ensure data integrity of safety outputs
Privacy & handoff
This role links to Ascendis Pharma's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.