Manager, ICSR Management Team - Job ID: 1982
Ascendis Pharma
August 21, 2026
Remote friendly (Palo Alto, CA)
United States
$150,000 - $160,000 USD yearly
Operations
Act as a Subject Matter Expert (SME) with regards to processing of Individual Case Safety Reports (ICSRs)
Responsibilities:
- Ensure all safety reports are processed in the safety database and reported per ICH-GCP, Health Authority regulations, company SOPs, Work Instructions, and business partner agreements
- Assist in oversight of the PV vendor processing ICSRs
- Triage incoming AE reports to identify special interest cases and those requiring expedited reporting
- Perform quality checks of processed ICSRs and provide feedback to the PV vendor
- Perform quality review of vendor information and feedback to improve source documentation quality/completeness
- Identify non-compliance or late ICSRs and escalate to management
- Ensure integrity of safety database outputs for aggregate reports and Health Authority requests
- Liaise cross-functionally to implement PV processes
- Provide input into departmental SOPs/Work Instructions and ensure regulatory compliance
- Provide input into training documents and train vendors on AE identification/reporting processes
- Identify process improvement opportunities; participate in optimization initiatives
- Support Case Transmission Verification (CTV) and SAE Reconciliation activities
Requirements/Skills:
- Bachelor’s degree in a healthcare field
- Minimum 5 years recent clinical trial and post-marketing case processing experience
- Working knowledge of validated Drug Safety databases (Argus preferred)
- MedDRA coding experience and global safety reporting regulatory requirements
- Foundational knowledge of FDA/EU safety regulations, GVP principles, and ICH Guidelines
- Ability to travel up to 20%
- Hybrid: on-site in Palo Alto, CA office 3 days/week
Benefits:
- 401(k) with company match; medical/dental/vision; life and AD&D; short/long-term disability; HSA; flexible spending; professional development; employee assistance; paid leave for new parents; other listed insurance and incentive plans.
Application instructions: None stated.
Responsibilities:
- Ensure all safety reports are processed in the safety database and reported per ICH-GCP, Health Authority regulations, company SOPs, Work Instructions, and business partner agreements
- Assist in oversight of the PV vendor processing ICSRs
- Triage incoming AE reports to identify special interest cases and those requiring expedited reporting
- Perform quality checks of processed ICSRs and provide feedback to the PV vendor
- Perform quality review of vendor information and feedback to improve source documentation quality/completeness
- Identify non-compliance or late ICSRs and escalate to management
- Ensure integrity of safety database outputs for aggregate reports and Health Authority requests
- Liaise cross-functionally to implement PV processes
- Provide input into departmental SOPs/Work Instructions and ensure regulatory compliance
- Provide input into training documents and train vendors on AE identification/reporting processes
- Identify process improvement opportunities; participate in optimization initiatives
- Support Case Transmission Verification (CTV) and SAE Reconciliation activities
Requirements/Skills:
- Bachelor’s degree in a healthcare field
- Minimum 5 years recent clinical trial and post-marketing case processing experience
- Working knowledge of validated Drug Safety databases (Argus preferred)
- MedDRA coding experience and global safety reporting regulatory requirements
- Foundational knowledge of FDA/EU safety regulations, GVP principles, and ICH Guidelines
- Ability to travel up to 20%
- Hybrid: on-site in Palo Alto, CA office 3 days/week
Benefits:
- 401(k) with company match; medical/dental/vision; life and AD&D; short/long-term disability; HSA; flexible spending; professional development; employee assistance; paid leave for new parents; other listed insurance and incentive plans.
Application instructions: None stated.