Manager, ICSR Management Team

Ascendis Pharma

Manager of ICSR Management Team overseeing Individual Case Safety Reports at Ascendis Pharma. Responsible for quality assurance, vendor oversight, and compliance in biopharmaceutical safety processes.

Posted 6/22/2026full-timePalo Alto • California • 🇺🇸 United StatesMid-LevelSenior💰 $150,000 - $160,000 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Act as a Subject Matter Expert (SME) with regards to processing of Individual Case Safety Reports (ICSRs)
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

Requirements

What you’ll need

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. Relocation is not offered for this position.

Benefits

Comp & perks

401(k) plan with company match
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

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Hard Skills & Tools

Individual Case Safety Reports (ICSRs) processingvalidated Drug Safety databasesMedDRA codingclinical trial case processingpost-marketing case processingquality check of processed ICSRsaggregate reports generationCase Transmission Verification (CTV)SAE Reconciliationprocess improvement

Soft Skills

collaborationtrainingoversightfeedback provisioncrisis managementcommunicationproblem-solvingattention to detailorganizational skillsleadership