Ascendis Pharma · 5 days ago
Associate Director, ICSR Management Team - Job ID: 1755CA
Palo Alto, CA
Full-time
Hybrid
Lead/Staff, Director/Executive
$180K/yr - $195K/yr
8+ years expAscendis Pharma is a dynamic, fast-growing global biopharmaceutical company advancing programs in Endocrinology Rare Disease and Oncology. The Associate Director, ICSR Management Team is responsible for overseeing ICSR processing activities, ensuring compliance with safety regulations, and collaborating with various teams to enhance pharmacovigilance practices.
BiotechnologyClinical TrialsHealth Care
Responsibilities
Act as a Subject Matter Expert (SME) with regards to processing of Individual Case Safety Reports (ICSRs) and provide strategic input on case processing activities for Ascendis products
Ensures that all safety reports received from any source for Ascendis Products are processed in the safety database and are reported according to ICH-GCP guidelines, Healthy Authority regulations and company SOPs, Work Instructions and Business Partner agreements
Responsible for operational activities of ICSRs processed by PV Vendor and provide feedback and guidance as applicable. Assists in the oversight of the PV Vendor processing ICSRs for Ascendis Products
Performs Quality Checks of processed ICSRs and provides feedback to PV Vendor as applicable
Coordinates follow up activities for missing or ambiguous safety information as appropriate
Support vendor oversight by monitoring performance metrics/KPIs
Provides input to assigned vendors to improve the quality of Adverse Event intake
Performs late case investigation and risk mitigation strategy. Ability to review late case(s) to determine Root Cause Analysis (RCA) and create Corrective Action and Preventative action (CAPA) as applicable
Oversee regulatory and departmental compliance by ensuring timely processing of ICSRs in the Safety Database and submission to Health Authorities or partners as applicable
Ensure any non-compliance or late ICSR are identified and ensure deviations are filed in accordance with Ascendis requirements
Ensure data integrity for safety data outputs from the Safety Database for aggregate reports, Health Authority requests or other safety requirements
Liaise with other functional groups for implementation of PV related processes requiring cross functional collaboration
Drafts and updates departmental SOPs, Work Instruction etc. as applicable and ensure compliance with regulatory guidelines and regulations
Responsible for identifying and developing training documents (i.e., SOPs) for the targeted audience (as needed)
Responsible for training GxP vendors on processes corresponding to identification and reporting of Adverse Events to Ascendis Global Patient Safety
Responsible for training Internal and External employees on the use of Ascendis Safety Database as assigned
Functions as a PV advisor to Ascendis Clinical Development Organizations, Medical Affairs, Commercial Organizations and PV staff as applicable
Identify opportunities for process improvements and participate in process optimization initiatives
Support Medical Safety Science team with activities related to signal detection, risk management and health authority responses as needed
Raise or increase awareness, knowledge and understanding of pharmacovigilance requirements by conducting education/training sessions with functional partners / vendors as required
Supports Case Transmission Verification (CTV) and SAE Reconciliation activities as needed
Collaborate with PV Information Technology team on implementation and maintenance of the Global Safety Database and Safety Reporting rules within the Safety Database
Reviews and provides input to Business Partner or Pharmacovigilance Agreements and Safety Data Exchange Agreements (SDEA) to ensure appropriate safety exchange requirements are established and adhered to
Contribute to the maintenance of Ascendis Pharmacovigilance System Master File (PSMF)
Through coordination with Ascendis GCP and PV Compliance team will provide appropriate representation during PV related regulatory inspections or internal quality assurance/corporate compliance audits
Work collaboratively with Vendor Management, Study Management, QPPV Office and Medical Safety Science teams for assigned activities
Is responsible for any assigned US applicable Risk Management Plan Implementation Coordination activities and associated tracking as necessary
Maintain selected oversight of activities within the scope of Ascendis PV group under the direction of Head, ICSR management (example: Local PV agreements, CRMs, Digital Media etc.)
Participate in relevant crisis management activities within the scope of Ascendis PV group
Qualification
Required
Bachelor's degree in a health care field with relevant pharmaceutical industry experience in drug safety
Minimum of 8 years recent experience in Pharmacovigilance
Experience with MedDRA coding and global safety reporting regulatory requirements
Expert knowledge of FDA safety regulations, ICH Guidelines, and other applicable regulatory guidance documents; working knowledge of global safety regulations
Ability to travel up to 20% of the time domestically and internationally
Preferred
Candidates with advanced scientific degrees and extensive drug safety experience is highly desired
Working knowledge of validated Drug Safety Databases (Argus 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
Company
Ascendis Pharma
Ascendis Pharma built a high-value pipeline that aims to change the clinical treatment paradigms.
1001-5000 employees
Funding
Current Stage
Public CompanyTotal Funding
$1.88BKey Investors
Royalty Pharma
2024-09-19Post Ipo Equity· $300M
2024-09-03Post Ipo Debt· $150M
2023-09-05Post Ipo Debt· $150M
Leadership Team
Ivanna Rosendal
Senior Director, IT Business Partner
Keren Tenenbaum
US General Counsel and Chief Compliance Officer
Recent News
2026-01-11
2026-01-11
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