Manager, ICSR Management Team - Job ID: 1982

Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology.

Here at Ascendis, we pride ourselves on exceptional science, visionary leadership, and skilled and passionate colleagues.

Guided by our core values of Patients, Science, and Passion, we use our TransCon® drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs.

Our culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. We offer a dynamic workplace for employees to grow and develop their skills.

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

• Ensure that all safety reports received from any source for Ascendis products are processed in the safety database and reported according to ICH-GCP guidelines, Health Authority regulations, company SOPs, Work Instructions and business partner agreements.
• Assist in the oversight of the PV vendor that processes ICSRs for Ascendis products.
• Participate in triage of incoming AE reports to identify cases of special interest and cases requiring expedited reporting to Health Authorities and business partners.
• Perform quality check of processed ICSRs and provide feedback to PV vendor.

• Perform quality review of information received from assigned vendors and provide feedback to improve the quality and completeness of source documentation.
• Ensure any non-compliance or late ICSR are identified and escalated to management.

· Ensure integrity of safety database outputs used for aggregate reports, Health Authority requests or other safety requirements.

· Liaise with other functional areas for implementation of PV related processes requiring cross functional collaboration.

· Provide input into departmental SOPs and Work Instructions and ensure compliance with regulatory guidelines and regulations.

· Provide input into training documents for the targeted audience.

· Train vendors on processes for identifying and reporting Adverse Events to Ascendis Global Patient Safety (GPS).

· Identify opportunities for process improvements and participate in optimization initiatives.

· Support Case Transmission Verification (CTV) and SAE Reconciliation activities

• Work collaboratively with Vendor Management, Study Management, QPPV Office and Medical Science teams for assigned activities
• Maintain selected oversight of activities within the scope of Ascendis PV group under the direction of Head, ICSR Management
• Participate in relevant crisis management activities within the scope of Ascendis PV group

• Works effectively, independently, and collaboratively
• Displays strong organizational skills, is detail oriented and adapts in a dynamic, fast paced environment
• Ability to interact as an effective team player, encouraging collaboration in a multifunctional and multidisciplinary team setting
• Excellent communication skills, both written and verbal
• Displays a high level of commitment

• Bachelor’s degree in a health care field.
• Minimum 5 years recent clinical trial and post-marketing case processing experience
• Working knowledge of validated Drug Safety databases (Argus preferred)
• Experience with MedDRA coding and global safety reporting regulatory requirements
• Strong foundational knowledge of FDA and EU safety regulations, GVP principles and ICH Guidelines
• Ability to travel up to 20% of the time domestically and internationally
• This is a hybrid position, requiring physical presence in the Palo Alto, CA office 3 days per week.