Patient Safety Physician or Medical Reviewer || WFH

Job Title: Medical Reviewer – Signal Detection

Summary

Responsibilities

• 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.
  

• 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
  

Additional Details

• Location: Mumbai, Maharashtra, India
  
• Mode of Work: Remote
  
• Department: Pharmacovigilance / Drug Safety
  
• Qualification: MBBS
  
• Must Have Hands-On Experience as a Medical Reviewer with Signal Detection Experience
  
• Experience Required: 5+ years as a Medical Reviewer
  
• Notice Period: Any
  
• Employment Type: Full Time
  
• Salary Range: Based on your Previous CTC