Medical Reviewer at EVERSANA
Company Description:
At EVERSANA, we are proud to be certified as a Great Place to Work globally. Our vision is to create a healthier world, driven by a dedicated team of over 7,000 employees who deliver next-generation commercialization services to the life sciences industry. We serve more than 650 clients, ranging from innovative biotech startups to established pharmaceutical companies, helping to bring groundbreaking therapies to market and support the patients who rely on them. Together, we make an impact every day.
We embrace diversity in backgrounds and experiences, prioritizing the improvement of patient lives worldwide. We believe our inclusive culture is cultivated by the unique skills and talents of our team members, who care deeply about EVERSANA, our clients, and the patients we serve.
Job Description
Role Overview
The primary focus of this position is to perform medical review, evaluation, and analysis of Individual Case Safety Reports (ICSRs), assisting clients with safety data and ensuring compliance with pharmacovigilance (PV) legislation and guidance.
Key Responsibilities
Perform medical reviews of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs), ensuring compliance with service level agreements and regulatory timelines.
Compose, edit, and medically review Analyses of Similar Events (AOSE) for expedited cases in accordance with regulatory requirements.
Serve as an internal consultant to pharmacovigilance case processing teams on supported projects.
Maintain a deep understanding of the scientific basis for therapies and drug-induced diseases, including knowledge of medical devices and the drug development process.
Stay updated on the product portfolio and safety profiles across therapeutic areas.
Engage in process improvement activities, including quality control processes.
Provide timely feedback to case processors regarding errors and discrepancies.
Assist in training and mentoring other case processing and medical review personnel.
Participate in organizational activities aligned with departmental objectives.
Maintain awareness of developments in medical safety and regulatory standards.
Job Expectations
Travel: <5%
Hours: 45 hours per week
Education and Experience
Qualifications: MBBS/MD/BDS/MDS
Experience: 1-2 years as a Medical Reviewer for ICSRs in pharmaceuticals, biotech, or medical devices; CRO experience is highly desirable.
Regulatory Knowledge: Expertise in international guidelines and country-specific regulatory requirements (FDA, ICH GCP, MHRA, PMDA, GVP Modules, EU Clinical Trial Directive).
Skills: Excellent interpersonal, organizational, written, and verbal communication skills.
Technical Proficiency: Hands-on experience with MS Office applications (Outlook, Excel, Word, PowerPoint).
Additional Information
Your information will be kept confidential according to EEO guidelines. We advise caution against recruitment fraud. EVERSANA will never ask for personal information or payment during the employment process.
Diversity, Equity & Inclusion are foundational to our success. We are an Equal Opportunity Employer, embracing the unique strengths and experiences of our employees who share a passion for innovation and improving patient lives.
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