Medical Safety Lead
Medical Safety Lead
Refined job description
ROLE
– Responsible for the drug surveillance program, including follow‑up risk assessment and relatedness to product on adverse reaction reports
– Oversight of safety in clinical trials and post‑marketing programs
– Participate in resolution of legal liability and ensure compliance with governmental regulations
– Provide trending and safety signal detection and risk management assessment throughout the product life cycle
– Support safety activities for clinical development teams
– Monitor clinical safety data, including literature, case reports, and signal detection activities
– Drive the application of AI‑enabled solutions to simplify and enhance pharmacovigilance processes
– Conduct medical assessment of individual adverse event cases and ensure accurate evaluation
– Identify, evaluate, and monitor safety signals using single‑case and aggregate data
– Contribute to responses for regulatory authorities and healthcare professional safety inquiries
– Support preparation of core safety documents, including clinical overviews and summary reports
– Provide medical input to aggregate safety reports and regulatory submissions
– Collaborate cross‑functionally to integrate safety insights across global development teams
– Guide adverse event coding, causality assessment, and interpretation of clinical safety data
REQUIREMENTS
– Fluency in written and spoken English
– Experience in clinical trial methodology, regulatory requirements, scientific methodology, and statistical principles, including authorship of scientific publications
– Strong ability to analyze, interpret, and clearly communicate clinical safety data to diverse stakeholders
– Proven experience contributing to safety reports and regulatory documentation
– Experience managing clinical safety issues
– Skills in Clinical Trials, Medical Information, Pharmacovigilance, Regulatory Compliance, Risk Management, and Safety Science
Full job description
Job Description Summary
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.
Job Description
Working Model: Hybrid (12 days/month in office)
#LI-Hybrid
Key accountabilities:
Monitor clinical safety data including literature case reports and signal detection activities
Drive 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 evaluation
Identify evaluate and monitor safety signals using single-case and aggregate data
Contribute to responses for regulatory authorities and healthcare professional safety inquiries
Support preparation of core safety documents including clinical overviews and summary reports
Provide medical input to aggregate safety reports and regulatory submissions
Collaborate cross-functionally to integrate safety insights across global development teams
Guide adverse event coding causality assessment and interpretation of clinical safety data
Essential 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 English
At 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 publications
Strong ability to analyse interpret and clearly communicate clinical safety data to diverse stakeholders
Experience 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 documentation
Desirable Skills
Experience of using professional AI tools and agents for process improvement is strongly preferred
Experience managing clinical safety issues
If 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!
Skills Desired
Clinical Trials Medical Information Pharmacovigilance Regulatory Compliance Risk Management Safety Science