Manager, Individual Case Safety Report, ICSR
Ascendis Pharma
full-time
Posted on:
Location Type: Hybrid
Location: Palo Alto • California • New Jersey • United States
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Salary
💰 $150,000 - $160,000 per year
About the role
- 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.
Requirements
- You hold a Bachelor’s degree in Life Sciences with relevant pharmaceutical industry experience in patient safety
- Proficiency 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
- 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
- Endocrinology Therapeutic Area experience (preferred)
Benefits
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
ICSR processingcase intakequality reviewCAPA supportsignal detectionrisk managementSOP developmentAE reportingPSMF maintenancevalidated drug safety databases
Soft Skills
collaborationcommunicationleadershiptrainingproblem-solvingorganizational skillsattention to detailadaptabilityinterpersonal skillsengagement with senior leaders