Patient Safety Physician or Medical Reviewer || WFH

Accountabilities:: 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. Requirements: MBBS degree is mandatory; postgraduate qualifications in Pharmacology, Clinical Research, or Drug Safety are preferred. At least 5 years of hands-on experience as a Medical Reviewer, with demonstrated expertise in signal detection and evaluation. Strong knowledge of pharmacovigilance processes, signal detection methodologies, and global drug safety regulations. Proficiency in safety databases such as Argus, ArisG, Veeva Safety, or similar platforms. Experience with disproportionality analysis and signal detection tools such as Empirica Signal. In-depth understanding of global pharmacovigilance regulations, including ICH E2E, ICH E2D, and GVP Modules. Strong clinical evaluation, medical writing, analytical, and decision-making skills. Excellent communication, presentation, and interpersonal abilities. Effective cross-cultural communication and collaboration skills. Strong critical thinking, problem-solving, and clinical judgment. Ability to manage priorities, maintain accurate documentation, and consistently meet deadlines. Benefits: Work arrangement: Fully remote, work-from-home opportunity in India. Employment type: Full-time, permanent position. Location: Mumbai, Maharashtra, India, with remote working flexibility. Salary: Compensation based on previous CTC and experience. Notice period: Open to candidates with any notice period. Career impact: Opportunity to contribute to global patient safety and pharmaceutical risk management. Professional environment: Collaboration with multidisciplinary teams across pharmacovigilance, clinical research, and regulatory affairs.