Director, ICSR Management Team - Job ID: 2018
Ascendis Pharma
August 24, 2026
Remote friendly (Palo Alto, CA)
United States
$220,000 - $235,000 USD yearly
Operations
Key Responsibilities
- Establish and manage an ICSR Management team; oversee budget, headcount, and organizational development.
- Provide strategic planning with senior management and act as an integral member of Global Patient Safety (GPS) leadership.
- Serve as SME for ICSR processing and strategic input for Ascendis products.
- Ensure safety reports are processed in the safety database and reported per ICH-GCP, health authority regulations, and company SOPs.
- Oversee PV vendor ICSR operations: quality checks, feedback, guidance, KPI monitoring, and improving adverse event intake quality.
- Coordinate follow-up for missing/ambiguous safety information; investigate late cases, perform RCA, and support CAPA.
- Ensure regulatory/dept compliance: timely safety database processing, Health Authority/partner submissions, and deviation handling.
- Maintain data integrity for safety outputs; support cross-functional PV process implementation.
- Draft/update SOPs and work instructions; develop training materials; train GxP vendors.
- Advise internal teams (Clinical Development, Medical Affairs, Commercial, PV staff) on pharmacovigilance requirements.
- Support signal detection/risk management and health authority responses; assist with CTV and SAE reconciliation.
- Collaborate with PV IT on safety database and reporting rules; review PV agreements/SDEA; maintain PV Business Continuity Plan (BCP).
Requirements
- Health Care Professional degree required (e.g., B. Pharm, PharmD, RN).
- Advanced scientific degree and extensive drug safety experience highly desired.
- 10+ years recent Pharmacovigilance experience.
- 5+ years people management experience preferred.
- Working knowledge of validated drug safety databases (Argus preferred); MedDRA coding; global safety reporting regulations.
- Expert knowledge of FDA safety regulations and ICH; ability to travel up to 20%.
Benefits
- 401(k) with company match; medical/dental/vision; Life & AD&D; short/long-term disability; pet and legal insurance; EAP; employee discounts; professional development; HSA/FSA; incentive compensation; accident/critical illness/hospital indemnity; mental health resources; paid parental leave.
- Establish and manage an ICSR Management team; oversee budget, headcount, and organizational development.
- Provide strategic planning with senior management and act as an integral member of Global Patient Safety (GPS) leadership.
- Serve as SME for ICSR processing and strategic input for Ascendis products.
- Ensure safety reports are processed in the safety database and reported per ICH-GCP, health authority regulations, and company SOPs.
- Oversee PV vendor ICSR operations: quality checks, feedback, guidance, KPI monitoring, and improving adverse event intake quality.
- Coordinate follow-up for missing/ambiguous safety information; investigate late cases, perform RCA, and support CAPA.
- Ensure regulatory/dept compliance: timely safety database processing, Health Authority/partner submissions, and deviation handling.
- Maintain data integrity for safety outputs; support cross-functional PV process implementation.
- Draft/update SOPs and work instructions; develop training materials; train GxP vendors.
- Advise internal teams (Clinical Development, Medical Affairs, Commercial, PV staff) on pharmacovigilance requirements.
- Support signal detection/risk management and health authority responses; assist with CTV and SAE reconciliation.
- Collaborate with PV IT on safety database and reporting rules; review PV agreements/SDEA; maintain PV Business Continuity Plan (BCP).
Requirements
- Health Care Professional degree required (e.g., B. Pharm, PharmD, RN).
- Advanced scientific degree and extensive drug safety experience highly desired.
- 10+ years recent Pharmacovigilance experience.
- 5+ years people management experience preferred.
- Working knowledge of validated drug safety databases (Argus preferred); MedDRA coding; global safety reporting regulations.
- Expert knowledge of FDA safety regulations and ICH; ability to travel up to 20%.
Benefits
- 401(k) with company match; medical/dental/vision; Life & AD&D; short/long-term disability; pet and legal insurance; EAP; employee discounts; professional development; HSA/FSA; incentive compensation; accident/critical illness/hospital indemnity; mental health resources; paid parental leave.