Medical Safety Lead

Responsible for the drug surveillance program including the necessary follow-up, risk assessment, and relatedness to product on adverse reaction reports, oversight of safety in clinical trials and post marketing programs. Participates in the resolution of any legal liability and complying with governmental regulations. Provides and contributes trending and safety signal detection and risk management assessment for the products’ life cycle. Provides safety support to the clinical development teams.

Working Model: Hybrid (12 days/month in office)#LI-Hybrid Key accountabilities: Monitor clinical safety data, including literature, case reports, and signal detection activitiesDrive the application of AI-enabled solutions to simplify and enhance pharmacovigilance processes, leveraging knowledge of AI agents and their use in medical safety.Conduct medical assessment of individual adverse event cases and ensure accurate evaluationIdentify, evaluate, and monitor safety signals using single-case and aggregate dataContribute to responses for regulatory authorities and healthcare professional safety inquiriesSupport preparation of core safety documents, including clinical overviews and summary reportsProvide medical input to aggregate safety reports and regulatory submissionsCollaborate cross-functionally to integrate safety insights across global development teamsGuide adverse event coding, causality assessment, and interpretation of clinical safety dataEssential Requirements:Degree in Pharmacy, Nursing, Pharmacology, Life Sciences, or a medical degree (medical degree required for roles involving medical review of individual case safety reports)Fluency in written and spoken EnglishAt least 3 years’ experience in drug development within a pharmaceutical company (including 2 years in patient safety at an operational or medical position is preferred)Experience in clinical trial methodology, regulatory requirements, scientific methodology, and statistical principles, including authorship of scientific publicationsStrong ability to analyse, interpret, and clearly communicate clinical safety data to diverse stakeholdersExperience in safety and cross-functional issue management (e.g., regulatory inquiries, compliance issues, labelling updates, and risk escalations)Proven experience contributing to safety reports and regulatory documentationDesirable Skills Experience of using professional AI tools and agents for process improvement is strongly preferredExperience managing clinical safety issuesIf you are passionate about patient safety and want to make a meaningful impact at scale, we encourage you to apply and join us in reimagining medicine together!