EVERSANA
EVERSANA is a comprehensive service provider focused on integrated commercial solutions for the life sciences industry. The company offers a wide range of services including advisory and management consulting, regulatory consulting, patient services, market access strategies, pricing and revenue management, medical affairs, and digital transformation. EVERSANA is known for its expertise in drug commercialization, enabling companies to effectively launch and manage pharmaceutical products. With a platform powered by data and analytics, EVERSANA addresses challenges related to drug pricing, market access, patient adherence, and product delivery, helping companies optimize their commercial strategies and enhance patient outcomes. The company emphasizes innovation and has been recognized for its use of AI and data analytics within the life sciences sector.
Regulatory • Management & Specialty Consulting • Research & Insights • Global Pricing Strategies • Patient
Medical Reviewer
March 25
EVERSANA
EVERSANA is a comprehensive service provider focused on integrated commercial solutions for the life sciences industry. The company offers a wide range of services including advisory and management consulting, regulatory consulting, patient services, market access strategies, pricing and revenue management, medical affairs, and digital transformation. EVERSANA is known for its expertise in drug commercialization, enabling companies to effectively launch and manage pharmaceutical products. With a platform powered by data and analytics, EVERSANA addresses challenges related to drug pricing, market access, patient adherence, and product delivery, helping companies optimize their commercial strategies and enhance patient outcomes. The company emphasizes innovation and has been recognized for its use of AI and data analytics within the life sciences sector.
Regulatory • Management & Specialty Consulting • Research & Insights • Global Pricing Strategies • Patient
📋 Description
• Perform medical review, evaluation, and analysis of Individual Case Safety Reports (ICSRs). • Assist clients with the safety data, compliance with pharmacovigilance (PV) legislation and guidance. • Perform medical review of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs). • Compose, edit, and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements. • Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported. • Deep understanding of the scientific basis for therapies and drug-induced diseases. • Knowledge of medical device, vaccines and drug development process. • Participate in organizational activities to meet objectives suitable for the role/area of expertise.
🎯 Requirements
• MBBS/MD/BDS/MDS • 1-2 years of experience as Medical Reviewer for ICSRs in pharmaceutical, biotech, medical device. • Regulatory guidelines expertise: knowledge of international guidelines and country specific regulatory requirements (FDA, ICH GCP, MHRA, Pharmaceuticals and Medical Devices Agency (PMDA), GVP Modules; respective EU Clinical Trial Directive etc.) • Excellent interpersonal and organizational skills. • Excellent written and verbal communication skills. • Must have hands on experience with MS Office applications (Outlook, Excel, Word, PowerPoint, etc.).
🏖️ Benefits
• All your information will be kept confidential according to EEO guidelines. • We are an Equal Opportunity Employer.
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