EVERSANA is a leading global provider of commercialization services to the life sciences industry, with over 7,000 employees across 650+ clients. The company aims to improve patient lives globally by helping bring innovative therapies to market. EVERSANA values diversity, inclusion, and expertise, and they prioritize creating a positive work culture where employees can thrive.
Job Description
The Medical Reviewer will perform medical reviews, evaluations, and analysis of Individual Case Safety Reports (ICSRs). The role involves assisting clients with safety data, ensuring compliance with pharmacovigilance (PV) legislation and guidelines, and handling all medical aspects of PV for clinical trials and post-marketing drug reactions.
Key Responsibilities
- Review & Analyze: Medical review of Adverse Events (AEs) and Adverse Drug Reactions (ADRs) including narrative content, coding, seriousness, causality, expectedness, and summaries.
- Regulatory Compliance: Compose and review Analyses of Similar Events (AOSE) for expedited cases in line with regulatory requirements.
- Consultation: Serve as an internal consultant for pharmacovigilance case processing teams.
- Product Knowledge: Maintain up-to-date knowledge of the safety profiles and product portfolios for various therapeutic areas.
- Training & Mentoring: Assist in the training and mentoring of other medical review personnel.
- Quality Control: Involvement in process improvements and maintaining industry awareness related to medical safety regulations.
Job Expectations
- Travel: <5%
- Work Hours: 45 hours per week
Required Qualifications
- Education: MBBS, MD, BDS, or MDS degree.
- Experience: 1-2 years of experience as a Medical Reviewer for ICSRs in pharmaceutical, biotech, or medical device industries. CRO experience is highly desirable.
- Regulatory Expertise: Knowledge of international regulatory guidelines (FDA, ICH GCP, MHRA, PMDA, GVP Modules, EU Clinical Trial Directive).
- Skills:
- Excellent interpersonal, organizational, and communication skills.
- Proficiency in MS Office (Outlook, Excel, Word, PowerPoint).
