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Patient Safety Physician, Medical Reviewer
Location
India
Posted
100 days ago
Salary
₹1,500K - ₹1,800K / year
Seniority
Senior
Job Description
Patient Safety Physician, Medical Reviewer
2COMS Consulting Pvt. Ltd.
• Perform medical review and assessment of Individual Case Safety Reports (ICSRs), including evaluation of seriousness, causality, expectedness, and clinical relevance. • Conduct signal detection and signal evaluation using safety databases and statistical tools such as disproportionality analysis. • Analyze aggregate safety data from clinical trials, post-marketing surveillance, and scientific literature to identify emerging safety trends. • Support the preparation and review of Periodic Safety Update Reports (PSURs), PBRERs, DSURs, and Risk Management Plans (RMPs). • Participate in signal management activities, including signal validation, prioritization, documentation, and escalation. • Provide medical input for benefit-risk assessments of marketed and investigational products. • Monitor and interpret safety trends and emerging risks from pharmacovigilance databases and external sources. • Collaborate with clinical, regulatory, epidemiology, and safety teams to evaluate signals and develop risk mitigation strategies. • Ensure compliance with global pharmacovigilance regulations (FDA, EMA, ICH E2E, E2D, GVP Modules). • Contribute to SOP development, safety governance meetings, and safety review committees. • Support responses to health authority queries and prepare for safety audits and inspections.
Job Requirements
- MBBS (Required)
- Postgraduate qualification in Pharmacology, Clinical Research, or Drug Safety (Preferred)
- 5+ years of hands-on experience as a Medical Reviewer with demonstrated expertise in signal detection and evaluation
- Strong knowledge of pharmacovigilance processes and signal detection methodologies
- Proficiency with safety databases (Argus, ArisG, Veeva Safety, etc.)
- Experience with disproportionality analysis and signal detection tools (e.g., Empirica Signal)
- In-depth understanding of global PV regulations (ICH E2E, E2D, GVP Modules)
- Proven clinical evaluation and medical writing skills
- Excellent analytical, communication, and decision-making abilities
- Strong presentation and interpersonal skills
- Effective intercultural communication and collaboration abilities
- Commitment to timely task completion, accurate documentation, and adherence to deadlines
- Demonstrated problem-solving and critical thinking skills.
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