Director, ICSR Management Team - Job ID: 2018

About the role

Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company advancing programs in Endocrinology Rare Disease and Oncology. Guided by core values of Patients, Science, and Passion, we use our TransCon® drug development platform to develop new and potentially best-in-class therapies addressing unmet medical needs. Our culture fosters a workplace where skilled, adaptable, and highly resourceful professionals can grow and make their mark.

The Director, ICSR Management Team reports to the Head, Global PV Operations within the Global Patient Safety (GPS) organization and is responsible for the oversight of all ICSR Management activities, including ICSR processing workflow management, submission, and follow-up activities.

Responsibilities

• Establish and manage a team of ICSR Management Leads to ensure adherence to pharmacovigilance regulations and guidelines.
• Provide managerial oversight of the assigned team regarding budget, headcount, and organizational development.
• Participate with senior management to establish strategic plans and objectives.
• Act as an integral member of the Global Patient Safety (GPS) leadership team.
• Serve as a Subject Matter Expert (SME) for processing Individual Case Safety Reports (ICSRs) and provide strategic input on case processing activities.
• Ensure all safety reports for Ascendis products are processed in the safety database and reported according to ICH-GCP guidelines, health authority regulations, and company SOPs.
• Oversee operational activities of ICSRs processed by PV vendors and provide feedback and guidance as applicable.
• Perform quality checks of processed ICSRs and provide feedback to PV vendors.
• Coordinate follow-up activities for missing or ambiguous safety information.
• Support vendor oversight by monitoring performance metrics/KPIs and provide input to improve the quality of adverse event intake.
• Perform late case investigation, root cause analysis (RCA), and create corrective and preventive actions (CAPA) as needed.
• Ensure timely processing of ICSRs in the safety database and submission to health authorities or partners, identifying and addressing non-compliance or late ICSRs.
• Ensure data integrity of safety data outputs for aggregate reports, health authority requests, or other safety requirements.
• Liaise with cross-functional groups for implementation of PV-related processes.
• Draft and update departmental SOPs, work instructions, and ensure compliance with regulatory guidelines.
• Develop training documents (e.g., SOPs) and train GxP vendors on processes for identifying and reporting adverse events.
• Function 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 team with signal detection, risk management, and health authority responses.
• Conduct education/training sessions to raise awareness and understanding of pharmacovigilance requirements.
• Support Case Transmission Verification (CTV) and SAE Reconciliation activities.
• Collaborate with the PV Information Technology team on implementation and maintenance of the Global Safety Database and safety reporting rules.
• Review and provide input to Business Partner or Pharmacovigilance Agreements and Safety Data Exchange Agreements (SDEA).
• Create, maintain, and implement the Business Continuity Plan (BCP) as needed.
• Contribute to the maintenance of the Ascendis Pharmacovigilance System Master File (PSMF).
• Provide representation during PV-related regulatory inspections or internal audits.
• Coordinate US Risk Management Plan implementation and associated tracking activities.
• Maintain oversight of activities within the Ascendis PV group (e.g., Local PV agreements, CRMs, Digital Media).
• Participate in relevant crisis management activities within the scope of the Ascendis PV group.

Requirements

• Health Care Professional degree required (e.g., B. Pharm, PharmD, RN); advanced scientific degrees and extensive drug safety experience highly desired.
• Minimum of 10 years of recent experience in Pharmacovigilance.
• Minimum of 5 years of people management experience (preferred).
• Working knowledge of validated Drug Safety Databases (Argus preferred).
• Experience with MedDRA coding and global safety reporting regulatory requirements.
• Expert knowledge of FDA safety regulations, ICH Guidelines, and other applicable regulatory guidance documents; working knowledge of global safety regulations.
• Ability to travel up to 20% of the time domestically and internationally.

Skills

• Works effectively, independently, and collaboratively.
• Strong organizational skills, detail-oriented, and adapts in a dynamic, fast-paced environment.
• Demonstrates ownership, initiative, and accountability.
• Effective team player encouraging collaboration in a multifunctional and multidisciplinary team setting.
• Excellent written and verbal communication skills with credibility and confidence.
• Sound strategic evaluation, analysis, and decision-making skills.
• High level of commitment and ability to achieve results.

Pay

The estimated salary range for this position is $220,000–$235,000. Actual salary determination depends on experience, qualifications, and geographic location. This position may be eligible for a discretionary annual bonus or incentive compensation plan, discretionary stock-based long-term incentives, and other incentive compensation plans.

Benefits

• 401(k) plan with company match.
• Medical, dental, and vision plans.
• Company-offered Life and Accidental Death & Dismemberment (AD&D) insurance.
• Company-provided short- and long-term disability benefits.
• Pet Insurance and Legal Insurance.
• Employee Assistance Program.
• Employee Discounts.
• Professional Development opportunities.
• Health Savings Account (HSA) and Flexible Spending Accounts.
• Accident, Critical Illness, and Hospital Indemnity Insurance.
• Mental Health resources.
• Paid leave benefits for new parents.