Medical Assessment and Signal Detection Lead (MD) GPS Medical Science- ID:2006b
Ascendis Pharma
August 25, 2026
Remote friendly (Princeton, NJ)
United States
Medical Affairs
Medical Assessment and Signal Detection Lead
Responsibilities:
- Conduct medical review, assessment, and approval of Individual Case Safety Reports (ICSRs) from clinical trials and post-marketing.
- Support Pharmacovigilance (PV) direction, standards, and processes for corporate safety monitoring.
- Perform Quality Control reviews of assigned cases to ensure accuracy, integrity, completeness, and medical review quality in the safety database.
- Liaise with Medical Monitors to ensure appropriate medical review/assessment for adverse event reports and non-clinical safety findings.
- Analyze and identify trends/concerns for Ascendis and key competitive products; identify and evaluate safety signals using single/aggregate case reports and relevant literature.
- Provide medical and safety input to expedited and aggregate safety reports (e.g., 15-day Alert Report, SUSAR, PSUR, US PADER, Annual Safety Report, DSUR, IND Annual Report).
- Collaborate with and provide PV guidance/support for interdepartmental/corporate initiatives; provide PV expertise to Ascendis or CRO/vendor staff when needed.
- Under direction of Head of GPS Medical Science, may lead/contribute to regulatory authority safety query responses.
- Monitor global safety regulatory/guideline changes and recommend updates to departmental policies/SOPs/systems.
Requirements:
- MD required.
- 5+ years’ pharma experience required, including thorough understanding of PV processes.
- Expertise in safety surveillance, signal detection, regulatory compliance, and benefit-risk assessment.
- Working knowledge of FDA/EMA PV regulations and ICH guidelines; strong collaboration/communication.
- Ability to work in an agile, fast-paced environment.
- Ability to travel up to 20%.
Benefits:
- 401(k) match; medical/dental/vision; life/AD&D; short/long-term disability; paid time off; HSA/FSA; incentive compensation plans; employee assistance, discounts, and other listed insurance benefits.
Location/Work setup:
- Hybrid; preferably Palo Alto, CA, or near Princeton, NJ.
Responsibilities:
- Conduct medical review, assessment, and approval of Individual Case Safety Reports (ICSRs) from clinical trials and post-marketing.
- Support Pharmacovigilance (PV) direction, standards, and processes for corporate safety monitoring.
- Perform Quality Control reviews of assigned cases to ensure accuracy, integrity, completeness, and medical review quality in the safety database.
- Liaise with Medical Monitors to ensure appropriate medical review/assessment for adverse event reports and non-clinical safety findings.
- Analyze and identify trends/concerns for Ascendis and key competitive products; identify and evaluate safety signals using single/aggregate case reports and relevant literature.
- Provide medical and safety input to expedited and aggregate safety reports (e.g., 15-day Alert Report, SUSAR, PSUR, US PADER, Annual Safety Report, DSUR, IND Annual Report).
- Collaborate with and provide PV guidance/support for interdepartmental/corporate initiatives; provide PV expertise to Ascendis or CRO/vendor staff when needed.
- Under direction of Head of GPS Medical Science, may lead/contribute to regulatory authority safety query responses.
- Monitor global safety regulatory/guideline changes and recommend updates to departmental policies/SOPs/systems.
Requirements:
- MD required.
- 5+ years’ pharma experience required, including thorough understanding of PV processes.
- Expertise in safety surveillance, signal detection, regulatory compliance, and benefit-risk assessment.
- Working knowledge of FDA/EMA PV regulations and ICH guidelines; strong collaboration/communication.
- Ability to work in an agile, fast-paced environment.
- Ability to travel up to 20%.
Benefits:
- 401(k) match; medical/dental/vision; life/AD&D; short/long-term disability; paid time off; HSA/FSA; incentive compensation plans; employee assistance, discounts, and other listed insurance benefits.
Location/Work setup:
- Hybrid; preferably Palo Alto, CA, or near Princeton, NJ.