This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Patient Safety Physician or Medical Reviewer | WFH based in India.
Are you an experienced medical professional passionate about patient safety and pharmacovigilance? This remote opportunity offers the chance to play a vital role in protecting patients by evaluating drug safety data and identifying potential risks. You will contribute to signal detection, medical review, and benefit-risk assessments for pharmaceutical products. Working in a dynamic, global environment, you will collaborate with multidisciplinary teams to ensure regulatory compliance and support safety-related decision-making. Your expertise will help shape risk mitigation strategies and maintain the integrity of product safety profiles. This role is ideal for a clinically experienced professional seeking to make a meaningful impact in drug safety and pharmacovigilance.
Accountabilities:
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Perform medical reviews and assessments of Individual Case Safety Reports (ICSRs), including seriousness, causality, expectedness, and clinical relevance.
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Conduct signal detection and evaluation using pharmacovigilance databases and statistical tools, including disproportionality analysis.
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Analyze aggregate safety data from clinical trials, post-marketing surveillance, and scientific literature to identify emerging safety trends.
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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).
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Participate in signal management activities, including signal validation, prioritization, documentation, and escalation.
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Provide medical expertise for benefit-risk assessments of marketed and investigational products.
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Monitor safety trends and emerging risks through pharmacovigilance databases and external sources.
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Collaborate with clinical, regulatory, epidemiology, and drug safety teams to evaluate signals and develop risk mitigation strategies.
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Ensure compliance with global pharmacovigilance regulations and guidelines, including FDA, EMA, ICH E2E, ICH E2D, and GVP Modules.
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Contribute to SOP development, safety governance meetings, and safety review committees.
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Support responses to health authority queries and contribute to safety audits and inspections.
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MBBS degree is mandatory; postgraduate qualifications in Pharmacology, Clinical Research, or Drug Safety are preferred.
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At least 5 years of hands-on experience as a Medical Reviewer, with demonstrated expertise in signal detection and evaluation.
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Strong knowledge of pharmacovigilance processes, signal detection methodologies, and global drug safety regulations.
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Proficiency in safety databases such as Argus, ArisG, Veeva Safety, or similar platforms.
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Experience with disproportionality analysis and signal detection tools such as Empirica Signal.
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In-depth understanding of global pharmacovigilance regulations, including ICH E2E, ICH E2D, and GVP Modules.
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Strong clinical evaluation, medical writing, analytical, and decision-making skills.
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Excellent communication, presentation, and interpersonal abilities.
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Effective cross-cultural communication and collaboration skills.
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Strong critical thinking, problem-solving, and clinical judgment.
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Ability to manage priorities, maintain accurate documentation, and consistently meet deadlines.
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Work arrangement: Fully remote, work-from-home opportunity in India.
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Employment type: Full-time, permanent position.
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Location: Mumbai, Maharashtra, India, with remote working flexibility.
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Salary: Compensation based on previous CTC and experience.
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Notice period: Open to candidates with any notice period.
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Career impact: Opportunity to contribute to global patient safety and pharmaceutical risk management.
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Professional environment: Collaboration with multidisciplinary teams across pharmacovigilance, clinical research, and regulatory affairs.