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 energetic, 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, re

📌 Patient Safety Physician or Medical Reviewer || WFH (Mumbai)
🏢 2COMs
📍 Mumbai