Medical Assessment and Signal Detection Lead (MD) GPS Medical Science- ID:2006b

Role: Medical Assessment and Signal Detection Lead in pharmacovigilance at Ascendis Pharma, responsible for medical review, safety signal detection, and regulatory reporting of adverse events from clinical trials and post-marketing. Responsibilities: perform medical assessment and approval of ICSRs, support PV department standards, conduct quality reviews, liaise with Medical Monitors, analyze safety trends, contribute to safety reports (e.g., SUSAR, PADER, PSUR), and guide safety queries. Additional duties include monitoring safety regulations, updating SOPs, and supporting regulatory inspections. Requirements: MD degree with 5+ years' pharma experience, expertise in safety surveillance, signal detection, and compliance with FDA, EMA, ICH guidelines. Skills: strong collaboration, communication, and adaptability in fast-paced environments; ability to travel up to 20%. High-Value: PV processes, global safety regulations, safety signal detection, safety reporting, regulatory interactions. WorkSetup: hybrid, preferably Palo Alto, CA, or near Princeton, NJ.