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

Ascendis Pharma is seeking an Associate Director to join the ICSR Management Team within the Global Patient Safety (GPS) organization. This role focuses on managing ICSR processing workflows, providing strategic input to case processing, and ensuring compliance with ICH-GCP guidelines and company SOPs. The ideal candidate will be a subject matter expert and possess strong organizational skills.

Requirements

• Bachelor’s degree in a health care field with relevant pharmaceutical industry experience.
• Advanced scientific degree and extensive drug safety experience (highly desired).
• Minimum of 8 years recent experience in Pharmacovigilance
• 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.
• Strong organizational skills, detail-oriented and adapts in a dynamic, fast paced environment.

Benefits

• 401(k) plan with company match
• Medical, dental, and vision plans
• Company-offered Life and Accidental Death & Dismemberment (AD&D) insurance
• Short and long-term disability benefits
• Pet Insurance and 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 for new parents