Patient Safety Physician, Medical Reviewer

Job not on LinkedIn

🕒 July 27

🇮🇳 India – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🔍🏥 Medical Reviewer

👻 Ghost score 51%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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2COMS Consulting Pvt. Ltd.

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1999

💼 Consulting

📦 Logistics

📣 Marketing

Consulting • Logistics • Marketing

2COMS Consulting Pvt. Ltd. is an India-based recruitment and staffing firm with decades of experience providing end-to-end talent solutions for employers and job seekers. The company offers general and IT staffing, apprenticeship management, hire-train-deploy programs, RPO and international recruitment, gig workforce services, and digital HR/recruitment technology solutions to streamline hiring and reduce training costs. With pan-India operations and clients across sectors like BPO/KPO, retail, and IT, 2COMS focuses on placing candidates, managing apprenticeships, and delivering HRTech-enabled recruitment outsourcing.

📋 Description

• 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

🏖️ Benefits

• Permanent employment • Remote work / WFH

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