Associate Director, ICSR Management Team

Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology.

Here at Ascendis, we pride ourselves on exceptional science, visionary leadership, and skilled and passionate colleagues.

Guided by our core values of Patients, Science, and Passion, we use our Trans Con® drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs.

Our culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. We offer a dynamic workplace for employees to grow and develop their skills.

The Associate Director, ICSR Management Team reports to the Director, Head, ICSR Management within the Global Patient Safety (GPS) organization. Under the direction of the Head, ICSR Management, this role is responsible for all assigned ICSR Management activities including ICSR processing workflow management, submission and follow-up activities.

• Act as a Subject Matter Expert (SME) with regards to processing of Individual Case Safety Reports (ICSRs) and provide strategic input on case processing activities for Ascendis products.
• Ensure that all safety reports received from any source for Ascendis products are processed in the safety database and are reported according to ICH-GCP guidelines, Health Authority regulations, and company SOPs, Work Instructions, and Business Partner agreements.
• Oversee operational activities of ICSRs processed by PV Vendor and provide feedback and guidance as applicable. Assist in the oversight of PV Vendor processing ICSRs for Ascendis products.
• Perform Quality Checks of processed ICSRs and provide feedback to PV Vendor as applicable.
• Coordinate follow-up activities for missing or ambiguous safety information as appropriate.
• Support vendor oversight by monitoring performance metrics/KPIs and provide input to assigned vendors to improve Adverse Event intake quality.
• Perform late case investigation and risk mitigation; review late cases to determine Root Cause Analysis (RCA) and create CAPA as applicable.
• Oversee regulatory and departmental compliance by ensuring timely processing of ICSRs in the Safety Database and submission to Health Authorities or partners as applicable.
• Identify and address non-compliance or late ICSRs and ensure deviations are filed in accordance with Ascendis requirements.
• Ensure data integrity for safety data outputs from the Safety Database for aggregate reports, Health Authority requests, or other safety requirements.
• Collaborate with other functional groups for cross-functional PV process implementation and updates to SOPs/Work Instructions as applicable.
• Identify and develop training documents for targeted audiences and train GxP vendors and internal/external employees on processes related to Adverse Event reporting and use of Ascendis Safety Database.
• Serve as PV advisor to Ascendis Clinical Development Organizations, Medical Affairs, Commercial, and PV staff as applicable.
• Identify opportunities for process improvements and participate in process optimization initiatives; support signal detection, risk management, and health authority responses as needed.
• Raise awareness of PV requirements through education/training sessions with partners and vendors.
• Support Case Transmission Verification (CTV) and SAE Reconciliation activities as needed.
• Collaborate with PV IT on the Global Safety Database implementation/maintenance and safety reporting rules; review Business Partner or PV-related agreements to ensure safety exchange requirements are met.

• Contribute to the maintenance of Ascendis Pharmacovigilance System Master File (PSMF).
• Represent PV during regulatory inspections or internal quality audits in coordination with GCP and PV Compliance teams.
• Work with Vendor Management, Study Management, QPPV Office, and Medical Safety Science teams for assigned activities.
• Coordinate US Risk Management Plan implementations and related tracking as necessary.
• Maintain oversight of activities…