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

Ascendis Pharma is a growing global biopharmaceutical company seeking an Associate Director, ICSR Management Team member to oversee critical safety reporting activities, particularly within the ICH-GCP guidelines. The role involves strategic input, operational support, quality checks, regulatory compliance, and training. The company fosters a culture of innovation and allows for professional growth within a dynamic environment.

Requirements

• Bachelor’s degree in a health care field with relevant pharmaceutical industry experience
• Minimum 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

Benefits

• Medical, dental, and vision plans
• Company-offered Life and Accidental Death & Dismemberment (AD&D) insurance
• Company-provided short and long-term disability benefits
• Unique offerings of 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