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Salary: USD 220,000 - 235,000 / annual
Ascendis Pharma, a dynamic global biopharmaceutical company, is seeking a Medical Assessment and Signal Detection Lead for its GPS Medical Science division. This hybrid role is based in Palo Alto, CA (with flexibility for candidates near Princeton, NJ).
You will lead 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 trends and concerns regarding Ascendis products and competitive products. You'll perform quality control reviews of safety cases, ensuring accuracy and completeness of information in the safety database.
Key activities include:
- Medical review and assessment of adverse event reports from clinical development and post-marketing
- Signal detection and analysis of single case reports, aggregate safety reports, and relevant literature
- Preparation of expedited and aggregate safety reports (15-day Alert Reports, SUSARs, PSURs, Annual Safety Reports, DSURs, IND Annual Reports)
- Collaboration with Medical Monitors in Clinical Development and Program Safety Leads
- Pharmacovigilance guidance and support for interdepartmental initiatives
- Responses to regulatory authority safety queries under direction of Head of GPS Medical Science
- Monitoring industry best practices and regulatory changes; recommending updates to departmental policies and SOPs
- Representation during PV-related regulatory inspections and compliance audits
You'll work in a fast-paced, agile environment with up to 20% travel (domestic and international). The role requires deep expertise in pharmacovigilance processes, safety surveillance, signal detection, regulatory compliance, and benefit-risk assessment. You must have working knowledge of FDA, EMA PV regulations, ICH Guidelines, and global safety regulations.
