Patient Safety Physician or Medical Reviewer || WFH

Required Skills:

Job Title: Medical Reviewer Signal Detection Job Summary We are seeking an experienced Medical Reviewer with expertise in Signal Detection to support pharmacovigilance activities and ensure the safety of pharmaceutical products. The candidate will be responsible for medical review of safety cases signal detection and evaluation risk assessment and collaboration with cross-functional teams to ensure regulatory compliance and patient safety. Key Responsibilities Perform medical review and assessment of Individual Case Safety Reports (ICSRs) including seriousness causality expectedness and medical evaluation. Conduct signal detection and signal evaluation using safety databases and statistical tools. Review and analyze aggregate safety data from multiple sources such as clinical trials post-marketing surveillance and literature. Support 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 and documentation. Provide medical input for benefit-risk assessment of products. Review and interpret safety trends and emerging risks from pharmacovigilance databases. Collaborate with clinical regulatory epidemiology and safety teams for signal evaluation and risk mitigation. Ensure compliance with global pharmacovigilance regulations (FDA EMA ICH guidelines). Contribute to SOP development safety governance meetings and safety review committees. Support health authority queries and safety audits/inspections. Required Skills & Competencies Strong knowledge of pharmacovigilance processes and signal detection methodologies. Experience with safety databases (Argus ArisG Veeva Safety etc.). Understanding of disproportionality analysis and signal detection tools. Knowledge of global PV regulations (ICH E2E E2D GVP Modules). Strong clinical evaluation and medical writing skills. Excellent analytical communication and decision-making abilities. Preferred Experience Experience in post-marketing safety surveillance and signal management. Exposure to statistical signal detection tools such as Empirica Signal or similar. Experience working in global pharmacovigilance teams. Education MBBS (Required) Postgraduate qualification in Pharmacology / Clinical Research / Drug Safety is a plus. Requirements Relevant educational background and experience in patient safety or related field Strong presentation and communication skills Effective intercultural work capabilities Commitment to timely completion of tasks and documentation Analytical and problem-solving skills Collaboration and teamwork abilities 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