2COMS Consulting Pvt. Ltd.
10,000+ employees
Founded 1999
🎯 Recruiter
👥 HR Tech
🤝 B2B
Recruitment • HR Tech • B2B
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.
Patient Safety Physician, Medical Reviewer
Job not on LinkedIn
🕒 March 13
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2COMS Consulting Pvt. Ltd.
10,000+ employees
Founded 1999
🎯 Recruiter
👥 HR Tech
🤝 B2B
Recruitment • HR Tech • B2B
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
• Remote work options • Health insurance • Professional development opportunities
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