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Ascendis Pharma, a global biopharmaceutical company advancing programs in endocrinology, rare disease, and oncology, seeks a Director of ICSR Management Team to lead pharmacovigilance operations. Reporting to the Head of Global PV Operations within the Global Patient Safety organization, this director-level role oversees all Individual Case Safety Report (ICSR) management activities, including processing workflows, regulatory submissions, and follow-up activities.
Key responsibilities include establishing and managing a team of ICSR Management Leads to ensure adherence to pharmacovigilance regulations and guidelines. The director will provide managerial oversight of budget, headcount, and organizational development while serving as an integral member of the Global Patient Safety leadership team. The role requires acting as a subject matter expert on ICSR processing, ensuring all safety reports are processed in the safety database according to ICH-GCP guidelines, Health Authority regulations, and company standard operating procedures.
Operational duties encompass quality checks of processed ICSRs, coordination of follow-up activities for missing information, vendor oversight and performance monitoring, and late case investigation with root cause analysis and corrective action development. The director will oversee regulatory compliance by ensuring timely ICSR processing and submission to Health Authorities, maintain data integrity of safety data outputs, and liaise with cross-functional teams on PV-related process implementation.
Additional responsibilities include drafting and updating departmental SOPs, developing training documents for targeted audiences, training GxP vendors on adverse event identification and reporting, and functioning as a PV advisor to clinical development, medical affairs, and commercial organizations. The role involves identifying process improvement opportunities, supporting signal detection and risk management activities, collaborating with PV IT on safety database implementation, and reviewing business partner and pharmacovigilance agreements. The director will maintain the Business Continuity Plan and represent Ascendis during PV regulatory inspections and internal audits.
