Patient Safety Physician or Medical Reviewer || WFH
Core
Medical professional evaluating drug safety data, performing medical reviews of Individual Case Safety Reports (ICSRs), and conducting signal detection to protect patients.
Role type
Senior Medical Reviewer (Pharmacovigilance)
Builds
Safety profiles, risk mitigation strategies, and regulatory reports for pharmaceutical products.
Domain
Pharmaceuticals / Pharmacovigilance
Required skills
Medical review of ICSRs, signal detection and evaluation, disproportionality analysis, aggregate safety data analysis, report preparation (PSURs, PBRERs, DSURs, RMPs), benefit-risk assessment, global pharmacovigilance regulations knowledge, safety database proficiency (Argus, ArisG, Veeva), signal management, SOP development, health authority query response.
Preferred skills
Postgraduate qualifications in Pharmacology, Clinical Research, or Drug Safety, experience with Empirica Signal.
Technologies
Argus, ArisG, Veeva Safety, Empirica Signal
Responsibilities
Perform medical reviews and assessments of Individual Case Safety Reports (ICSRs), including seriousness, causality, expectedness, and clinical relevance. Conduct signal detection and evaluation using pharmacovigilance databases and statistical tools, including disproportionality analysis. Analyze aggregate safety data from clinical trials, post-marketing surveillance, and scientific literature to identify emerging safety trends. Contribute to the preparation and review of Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Development Safety Update Reports (DSURs), and Risk Management Plans (RMPs). Participate in signal management activities, including signal validation, prioritization, documentation, and escalation. Provide medical expertise for benefit-risk assessments of marketed and investigational products. Monitor safety trends and emerging risks through pharmacovigilance databases and external sources. Collaborate with clinical, regulatory, epidemiology, and drug safety teams to evaluate signals and develop risk mitigation strategies. Ensure compliance with global pharmacovigilance regulations and guidelines, including FDA, EMA, ICH E2E, ICH E2D, and GVP Modules. Contribute to SOP development, safety governance meetings, and safety review committees. Support responses to health authority queries and contribute to safety audits and inspections.
Seniority
Senior, hands-on IC