Director, Head, ICSR Management Team - Job ID: 1598

Ascendis Pharma is a fast-growing, global biopharmaceutical company seeking a Director, Head, ICSR Management Team member. This role is responsible for overseeing all ICSR Management activities, including processing, compliance, and risk mitigation. The position requires leadership and management of the ICSR Management team, and collaboration with other teams like Patient Safety and Clinical Development.

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 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
• Ability to travel up to 20% of the time domestically and internationally

Benefits

• 401(k) plan
• Medical, dental, and vision plans
• Life and Accidental Death & Dismemberment (AD&D) insurance
• Short and long-term disability benefits
• Pet Insurance
• Legal Insurance
• Employee Assistance Program
• Employee Discounts
• Professional Development
• Health Saving Account (HSA)
• Flexible Spending Accounts
• Various incentive compensation plans
• Accident, Critical Illness, and Hospital Indemnity Insurance
• Mental Health resources
• Paid leave benefits