Medical Assessment and Signal Detection Lead (MD) GPS Medical Science- ID:2006b
Ascendis Pharma
August 25, 2026
Remote friendly (Palo Alto, CA)
United States
Medical Affairs
Responsibilities:
- Conduct medical review, assessment, and approval of Individual Case Safety Reports (ICSRs) from clinical trials and post-marketing.
- Support Pharmacovigilance direction, standards, and processes for corporate safety monitoring.
- Perform Quality Control reviews of assigned cases to ensure accuracy, integrity, completeness, and correct safety database entry.
- Liaise with Medical Monitors to ensure appropriate medical review for adverse event reports and non-clinical safety findings.
- Analyze and identify trends/concerns and evaluate safety signals using single case reports, aggregate safety reports, and relevant literature.
- Provide medical and safety input to expedited/aggregate safety reports (e.g., 15-day Alert Report, SUSAR, PSUR, US PADER, Annual Safety Report, DSUR, IND Annual Report).
- Collaborate with and provide pharmacovigilance guidance for interdepartmental/corporate initiatives; advise Ascendis and CRO/Vendor staff as needed.
- Under Head of GPS Medical Science direction, support timely Regulatory Authority safety query responses.
Requirements:
- 5+ years’ pharma experience with a thorough understanding of PV processes.
- MD required.
Required/Preferred Skills:
- Expertise in safety surveillance, signal detection, regulatory compliance, and benefit-risk assessment.
- Working knowledge of FDA/EMA PV regulations, ICH guidelines, and global safety regulations.
- Strong collaboration and communication skills; ability to work in an agile, fast-paced environment.
- Ability to travel up to 20%.
Benefits:
- 401(k) with company match; medical/dental/vision; life and AD&D; short/long-term disability; paid time off; HSA; flexible spending; various incentive plans and other listed benefits.
Application:
- Hybrid role (prefer Palo Alto, CA; also open to those near Princeton, NJ).
- Conduct medical review, assessment, and approval of Individual Case Safety Reports (ICSRs) from clinical trials and post-marketing.
- Support Pharmacovigilance direction, standards, and processes for corporate safety monitoring.
- Perform Quality Control reviews of assigned cases to ensure accuracy, integrity, completeness, and correct safety database entry.
- Liaise with Medical Monitors to ensure appropriate medical review for adverse event reports and non-clinical safety findings.
- Analyze and identify trends/concerns and evaluate safety signals using single case reports, aggregate safety reports, and relevant literature.
- Provide medical and safety input to expedited/aggregate safety reports (e.g., 15-day Alert Report, SUSAR, PSUR, US PADER, Annual Safety Report, DSUR, IND Annual Report).
- Collaborate with and provide pharmacovigilance guidance for interdepartmental/corporate initiatives; advise Ascendis and CRO/Vendor staff as needed.
- Under Head of GPS Medical Science direction, support timely Regulatory Authority safety query responses.
Requirements:
- 5+ years’ pharma experience with a thorough understanding of PV processes.
- MD required.
Required/Preferred Skills:
- Expertise in safety surveillance, signal detection, regulatory compliance, and benefit-risk assessment.
- Working knowledge of FDA/EMA PV regulations, ICH guidelines, and global safety regulations.
- Strong collaboration and communication skills; ability to work in an agile, fast-paced environment.
- Ability to travel up to 20%.
Benefits:
- 401(k) with company match; medical/dental/vision; life and AD&D; short/long-term disability; paid time off; HSA; flexible spending; various incentive plans and other listed benefits.
Application:
- Hybrid role (prefer Palo Alto, CA; also open to those near Princeton, NJ).