Manager, Individual Case Safety Report (ICSR) - Job ID: 1755CANJ

Ascendis Pharma•Palo Alto, CA

2h•$180 - $195•Hybrid

About The Position

Are you passionate about collaborating across teams to ensure timely, accurate and compliant safety reporting worldwide? Ascendis Pharma is seeking a passionate ICSR Manager to support our growing portfolio. We are a dynamic, global biopharmaceutical company headquartered in Denmark with hubs in Palo Alto, CA and Princeton, NJ. Come join us at Ascendis Pharma, where our core values --- Patients, Science & Passion, drive us to deliver best-in-class therapies that address critical unmet needs. The role The Manager, ICSR Management, plays a critical role within Global Patient Safety, supporting end-to-end ICSR workflow, including case processing, submission, and follow-up activities. Reporting to the Director, Head of ICSR Management, you will help strengthen pharmacovigilance operations, contribute to Ascendis Pharma’s expanding global presence, and support efficiency and automation initiatives that advance patient safety. As part of our global team, you will collaborate with highly skilled and dedicated colleagues to advance our growing and innovative product pipeline. You will: ICSR Processing & Oversight Manage day-to-day ICSR operations, including case intake, processing, quality review, follow-up, submissions, late case investigations, and CAPA support. Ensure timely, accurate, and compliant case processing in accordance with regulations, SOPs, partner agreements, and internal standards. Support the oversight of PV vendor performance through guidance, quality review, and KPI monitoring. Safety Data Quality & Cross-Functional Collaboration Ensure accuracy and integrity of safety data used for aggregate reports, regulatory requests, and internal safety activities. Support signal detection, risk management activities, and responses to health authorities. Collaborate across Global Regulatory Affairs, Clinical Development, Medical Affairs, Commercial, QPPV Office, Study Management, Vendor Management, Medical Safety Science, and PV IT on safety processes and system enhancements. Training & Process Governance Assist in developing and maintaining SOPs, Work Instructions, and PV process documentation. Provide PV training and subject-matter expertise to internal teams, external partners, and GxP vendors, including safety database use and AE reporting. Support inspections, audits, and compliance activities, including alignment with SDEAs and safety exchange requirements. Systems, Process Optimization & Additional PV Responsibilities Contribute to operational improvements and safety system updates in partnership with PV IT. Support Case Transmission Verification, SAE reconciliation, PSMF maintenance, and US Risk Management Plan implementation/tracking. Maintain oversight of designated PV operational areas (e.g., Local PV agreements, CRM, digital media) and participate in crisis management activities as needed.

Requirements

You hold a Bachelor’s degree in Life Sciences with relevant pharmaceutical industry experience in patient safety and are proficient in English at a professional level, both written and spoken.
Four to six years of recent pharmacovigilance experience, including hands-on execution of ICSR processing and experience supporting broader PV operations.
Previous experience with validated drug safety databases (preference for Argus)
Strong knowledge of global safety regulations, ICH guidelines, and applicable PV regulatory guidance.
Demonstrated ability to work collaboratively and comfortably engage with senior leaders within Patient Safety, cross-functionally, and with external partners
A passion for advancing innovative therapies that address unmet medical needs for patients with Rare Endocrine Diseases.
Comfortable balancing practical, hands-on execution with broader operational thinking and team collaboration.
Comfortable navigating ambiguity and can adapt quickly to shifting priorities in a global matrix environment.
A consistent track record of delivering high quality results in dynamic, fast paced settings where processes and expectations evolve over time.
Ability to travel up to 20% of the time domestically and internationally

Nice To Haves

Endocrinology Therapeutic Area experience (preferred).

Responsibilities

Manage day-to-day ICSR operations, including case intake, processing, quality review, follow-up, submissions, late case investigations, and CAPA support.
Ensure timely, accurate, and compliant case processing in accordance with regulations, SOPs, partner agreements, and internal standards.
Support the oversight of PV vendor performance through guidance, quality review, and KPI monitoring.
Ensure accuracy and integrity of safety data used for aggregate reports, regulatory requests, and internal safety activities.
Support signal detection, risk management activities, and responses to health authorities.
Collaborate across Global Regulatory Affairs, Clinical Development, Medical Affairs, Commercial, QPPV Office, Study Management, Vendor Management, Medical Safety Science, and PV IT on safety processes and system enhancements.
Assist in developing and maintaining SOPs, Work Instructions, and PV process documentation.
Provide PV training and subject-matter expertise to internal teams, external partners, and GxP vendors, including safety database use and AE reporting.
Support inspections, audits, and compliance activities, including alignment with SDEAs and safety exchange requirements.
Contribute to operational improvements and safety system updates in partnership with PV IT.
Support Case Transmission Verification, SAE reconciliation, PSMF maintenance, and US Risk Management Plan implementation/tracking.
Maintain oversight of designated PV operational areas (e.g., Local PV agreements, CRM, digital media) and participate in crisis management activities as needed.