Medical Assessment and Signal Detection Lead (MD) - GPS Medical Science

About the role

Ascendis Pharma, a global biopharmaceutical company focused on Endocrinology, Rare Disease and Oncology, is hiring a Medical Assessment and Signal Detection Lead for its GPS Medical Science function. The role covers the medical review, assessment and approval of Individual Case Safety Reports (ICSRs) from clinical trials and post-marketing, performs signal detection, works with program safety leads and ensures quality with the PV operations team. It is a hybrid role, preferably based in Palo Alto, CA, open to candidates living near the Princeton, NJ office.

Key responsibilities

• Review, assess and approve ICSRs from clinical trials and post-marketing
• Support the Pharmacovigilance Department's direction, standards and processes for corporate safety monitoring
• Perform quality control reviews of cases to ensure accurate, complete information in the safety database
• Liaise with Medical Monitors in Clinical Development on adverse event reports and non-clinical safety findings
• Analyse, identify and report safety trends and signals from single cases, aggregate reports and relevant literature
• Provide medical and safety input to expedited and aggregate safety reports (e.g. 15-day Alert Report, SUSAR, PSUR, DSUR)
• Support interdepartmental initiatives, advise CRO/vendor staff, and respond to regulatory authority safety queries under the Head of GPS Medical Science
• Monitor regulatory changes and recommend updates to policies, SOPs and systems; represent the department in PV-related regulatory inspections and audits

Required profile

• Medical degree (MD required)
• 5+ years of pharma experience, including a thorough understanding of PV processes
• Ability to travel up to 20% domestically and internationally

Required skills

• 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

What we offer

• Estimated salary of $220-235k DOE, with possible discretionary bonus, stock-based long-term incentives and paid time off
• 401(k) with company match, medical, dental and vision plans, life and AD&D insurance, disability benefits
• Pet and legal insurance, employee assistance program, professional development, HSA and flexible spending accounts
• Mental health resources and paid leave for new parents