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
Proficiency with safety databases (Argus, ArisG, Veeva Safety, etc.) and experience with disproportionality analysis and signal detection tools (e.g., Empirica Signal)
Requirements:
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.
Support the preparation and review of PSURs, PBRERs, DSURs, and Risk Management Plans (RMPs).
Participate in signal management activities, including signal validation, prioritization, documentation, and escalation.
Job description
Job Title: Medical Reviewer – Signal Detection
Summary
We are seeking an experienced Medical Reviewer with expertise in Signal Detection to play a critical role in pharmacovigilance operations, ensuring the ongoing safety and regulatory compliance of pharmaceutical products. The ideal candidate will be responsible for the medical evaluation of Individual Case Safety Reports (ICSRs), identification and assessment of safety signals, and proactive risk evaluation using advanced safety databases and statistical tools. This role requires a strong clinical background, deep understanding of global pharmacovigilance regulations, and the ability to collaborate effectively across cross-functional teams. The Medical Reviewer will contribute to key safety deliverables such as PSURs, PBRERs, DSURs, and Risk Management Plans, while supporting safety governance, regulatory submissions, and audits. This position is essential in safeguarding patient safety and maintaining the integrity of product safety profiles in a dynamic, global environment.
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.
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
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
