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Salary: USD 220,000 - 235,000 / annual
Ascendis Pharma, a global biopharmaceutical company advancing programs in Endocrinology Rare Disease and Oncology, seeks a Medical Assessment and Signal Detection Lead for its GPS Medical Science group. This hybrid role is based in Palo Alto, CA (with flexibility for candidates near Princeton, NJ).
You will lead the medical review, assessment, and approval of Individual Case Safety Reports (ICSRs) from clinical trials and post-marketing surveillance. Your core responsibilities include conducting signal detection activities to identify and evaluate safety signals through analysis of single case reports, aggregate safety reports, and relevant literature. You'll perform quality control reviews to ensure accuracy and integrity of safety database entries, collaborate with Medical Monitors in Clinical Development on adverse event assessment, and provide medical and safety input to expedited and aggregate safety reports (15-day Alert Reports, SUSARs, PSURs, Annual Safety Reports, DSURs, IND Annual Reports, etc.).
You'll work closely with Program Safety Leads and the PV operations team, providing pharmacovigilance guidance and support for interdepartmental initiatives. Additional responsibilities include monitoring industry best practices and regulatory changes, supporting departmental policy and SOP development, representing the department during regulatory inspections and compliance audits, and responding to safety queries from regulatory authorities under the direction of the Head of GPS Medical Science. Travel up to 20% domestically and internationally is required.
You bring 5+ years of pharma experience with deep expertise in pharmacovigilance processes, safety surveillance, signal detection, regulatory compliance, and benefit-risk assessment. You have working knowledge of FDA, EMA PV regulations, ICH Guidelines, and global safety regulations. Strong collaboration, communication, and agile problem-solving skills are essential. You thrive in fast-paced environments and can manage complex safety assessments with precision.
