Associate Director, ICSR Management Team

Associate Director, ICSR Management Team (Job )

Ascendis Pharma is a dynamic, fast‑growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. We advance programs in Endocrinology Rare Disease and Oncology, using our Trans Con® drug development platform to develop new and potentially best‑in‑class therapies for unmet medical needs.

• Act as a subject matter expert on ICSR processing and provide strategic input on case processing activities for Ascendis products.
• Ensure all safety reports from any source for Ascendis products are processed in the safety database and reported according to ICH‑GCP guidelines, Health Authority regulations, and company SOPs, work instructions, and business partner agreements.
• Oversee operational activities of PCSRs processed by the PV vendor, providing feedback and guidance as required and assisting with oversight of the PV vendor’s processing of ACSRs for Ascendis products.
• Perform quality checks of processed ACSRs and provide feedback to the vendor as applicable.
• Coordinate follow‑up activities for missing or ambiguous safety information as appropriate.
• Support vendor oversight by monitoring performance metrics/KPIs.
• Provide input to assigned vendors to improve the quality of adverse event intake.
• Conduct late case investigations and risk mitigation strategy, including root cause analysis and creation of corrective and preventative actions (CAPA) as applicable.
• Oversee regulatory and departmental compliance by ensuring timely processing of ACSRs in the safety database and submission to health authorities or partners as required.
• Identify non‑compliance or late ACSRs 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.
• Liaise with other functional groups for implementation of PV‑related processes requiring cross‑functional collaboration.
• Draft and update departmental SOPs, work instructions, and other documentation as applicable, ensuring compliance with regulatory guidelines.
• Identify and develop training documents for the targeted audience (as needed) and train GxP vendors on processes related to identification and reporting of adverse events.
• Train internal and external employees on the use of the Ascendis safety database as assigned.
• Serve as a PV advisor to Ascendis clinical development, medical affairs, commercial organizations, and PV staff.
• Identify opportunities for process improvements and participate in process optimization initiatives.
• Support the medical safety science team with activities related to signal detection, risk management, and health authority responses as needed.
• Raise awareness and understanding of pharmacovigilance requirements by conducting education and training sessions with functional partners and vendors as required.
• Support case transmission verification (CTV) and SAE reconciliation activities as needed.
• Collaborate with the PV information technology team on implementation and maintenance of the global safety database and safety reporting rules within the safety database.
• Review and provide input to business partner or pharmacovigilance agreements and safety data exchange agreements (SDEA) to ensure appropriate safety exchange requirements are established and adhered to.

• Contribute to the maintenance of the Ascendis pharmacovigilance system master file (PSMF).
• Coordinate with the Ascendis GCP and PV compliance team to provide appropriate representation during PV‑related regulatory inspections or internal quality assurance/corporate compliance audits.
• Work collaboratively with vendor management, study management, QPPV office, and medical safety science teams for assigned activities.
• Serve as the lead for US‑applicable risk management plan implementation coordination activities and associated tracking as necessary.
• Maintain selected oversight of activities within the scope of the Ascendis PV group under the direction of the Head of ICSR management, such as local PV agreements,…