Safety Physician
Core
Provides scientific and medical expertise in Safety Evaluation and Risk Management (SERM) across clinical development and post-marketing products, ensuring robust safety assessment, signal detection, and regulatory compliance.
Role type
Senior IC Safety Physician / SERM Scientist
Builds
Safety reports, Risk Management Plans, and regulatory submissions for pharmaceutical products
Domain
Life Sciences / Pharmacovigilance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Signal detection and evaluation, aggregate safety report authoring (PSUR/PBRER/DSUR), benefit-risk assessment, knowledge of ICH/GVP/CIOMS guidelines, regulatory compliance, risk mitigation strategy development
Preferred skills
Advanced degree in Life Sciences/Pharmacy/Biomedical Sciences, experience in global matrix environments, stakeholder communication
Technologies
Safety databases, literature review tools
Responsibilities
Perform signal detection, evaluation, and risk assessment for assigned products; Author and review aggregate safety reports and regulatory submissions; Identify, assess, and escalate safety signals with recommended risk mitigation strategies; Contribute to protocols, program documents, and safety governance activities; Support health authority responses, audits, and inspection readiness activities; Drive process improvements and ensure compliance with global PV regulations
Seniority
Mid-Senior, hands-on IC
