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

Ascendis Pharma is seeking a Director, Head, ICSR Management Team to oversee all aspects of ICSR Processing, including submission, follow-up, and quality assurance. This role focuses on leadership, people management, strategic planning, and ensuring adherence to ICH-GCP guidelines and company SOPs. Ascendis is dedicated to developing innovative therapies in high-impact areas such as Endocrinology and Oncology, valuing a collaborative and supportive work environment.

Requirements

• Health Care Professional degree (e.g., B. Pharm, PharmD, RN etc.)
• Advanced scientific degrees (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
• Working knowledge of business continuity planning

Benefits

• 401(k) plan with company match
• 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