Associate Director, ICSR Management Team - Job ID: 1755CA

Role Summary

The Associate Director, ICSR Management Team is responsible for all assigned Individual Case Safety Report (ICSR) management activities, including ICSR processing workflow management, submission, and follow-up. The role reports to the Director, Head, ICSR Management within Global Patient Safety (GPS) and supports oversight of ICSR processing and vendor activities to ensure compliance with regulatory guidelines and company SOPs.

Responsibilities

• Act as a Subject Matter Expert (SME) for processing ICSRs and provide strategic input on case processing activities for Ascendis products.
• Ensure safety reports from all sources are processed in the safety database and reported per ICH-GCP guidelines, health authority regulations, and company SOPs.
• Oversee operational activities of ICSRs processed by PV Vendor and provide feedback/guidance; assist in vendor oversight.
• Perform quality checks of processed ICSRs and provide feedback to PV Vendor.
• Coordinate follow-up activities for missing or ambiguous safety information; monitor vendor performance metrics/KPIs.
• Provide input to vendors to improve Adverse Event intake quality.
• Perform late case investigations and risk mitigation; conduct RCA and create CAPA as applicable.
• Ensure regulatory and departmental compliance with timely processing and submission of ICSRs; identify non-compliance or late ICSRs and file deviations as required.
• Ensure data integrity for safety data outputs and liaise with cross-functional groups for PV process implementations.
• Draft/update departmental SOPs/Work Instructions; develop training materials for targeted audiences and train GxP vendors and internal/external staff on PV processes.
• Serve as PV advisor to Clinical Development, Medical Affairs, Commercial, and PV staff; identify process improvements and participate in optimization initiatives.
• Support Medical Safety Science activities related to signal detection, risk management, and health authority responses; conduct education/training sessions on PV requirements.
• Support Case Transmission Verification (CTV) and SAE Reconciliation as needed; collaborate with PV IT on safety database maintenance and rules.
• Review and provide input to Pharmacovigilance/Business Partner Agreements and Safety Data Exchange Agreements (SDEA) to ensure safety exchange requirements are met.
• Contribute to additional activities such as maintaining the Pharmacovigilance System Master File (PSMF) and representation during PV regulatory inspections or audits.
• Collaborate with Vendor Management, Study Management, QPPV Office, and Medical Safety Science teams; coordinate on US Risk Management Plan implementation and related tracking.
• Maintain oversight of activities within the scope of the Ascendis PV group under the Head of ICSR Management; participate in crisis management activities as needed.

Qualifications

• Required: Bachelor‚Äôs degree in a health care field with relevant pharmaceutical industry experience in drug safety.
• Preferred: Advanced scientific degree and extensive drug safety experience.
• Required: Minimum of 8 years of recent experience in Pharmacovigilance.
• Required: Working knowledge of validated Drug Safety Databases (Argus preferred).
• Required: Experience with MedDRA coding and global safety reporting regulatory requirements.
• Required: Expert knowledge of FDA safety regulations, ICH Guidelines, and other applicable regulatory guidance; working knowledge of global safety regulations.
• Required: Ability to travel up to 20% of the time domestically and internationally.

Skills

• Works effectively both independently and collaboratively
• Strong organizational skills, detail-oriented, and adaptable to a dynamic environment
• Ownership, initiative, and accountability
• Effective team player with cross-functional collaboration
• Excellent written and verbal communication with credibility and confidence
• Strategic evaluation, analysis, and decision-making skills
• Commitment and reliability