Medical Reviewer
Employees can work remotely
Full-time
Department: Clinical & Medical
Job Family: Medical & Regulatory Affairs
Company Description:
At EVERSANA, we are proud to be certified as a Great Place to Work across the globe. Our mission is to create a healthier world by delivering next-generation commercialization services to the life sciences industry. Our global team of over 7,000 employees is dedicated to serving more than 650 clients, ranging from innovative biotech start-ups to established pharmaceutical companies. We provide innovative solutions that help bring therapies to market and support the patients who rely on them.
We value diversity and inclusion, believing that a variety of perspectives enhances our work. We seek team members who care deeply about EVERSANA, our people, clients, and most importantly, the patients we serve.
Job Description:
JOB DESCRIPTION:
The primary responsibility of this role is to perform medical review, evaluation, and analysis of Individual Case Safety Reports (ICSRs), assist clients with safety data, ensure compliance with pharmacovigilance (PV) legislation, and handle all medical aspects of PV.
KEY RESPONSIBILITIES:
Perform medical review of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs), including narrative content, queries, coding, expectedness, seriousness, causality, and company summary within stipulated timelines to comply with service level agreements and regulatory guidelines.
Compose, edit, and medically review Analyses of Similar Events (AOSE) for expedited cases based on regulatory requirements.
Serve as an internal consultant to pharmacovigilance case processing teams.
Develop and maintain in-depth knowledge of product portfolios and safety profiles across therapeutic areas.
Implement process improvements, including quality control measures.
Provide timely feedback to case processors on errors/discrepancies.
Assist in training/mentoring of case processing/medical review personnel.
Participate in organizational initiatives aligned with expertise.
Stay updated on industry developments in medical safety and regulatory compliance.
EXPECTATIONS:
Travel: <5%
Hours: 45 hours per week
EDUCATION AND EXPERIENCE:
MBBS/MD/BDS/MDS
1-2 years of experience as a Medical Reviewer for ICSRs in pharmaceutical, biotech, medical device industries, or CROs.
Strong knowledge of international regulatory guidelines (FDA, ICH GCP, MHRA, PMDA, GVP Modules, EU Clinical Trial Directive, etc.).
Excellent interpersonal, organizational, written, and verbal communication skills.
Proficiency in MS Office applications (Outlook, Excel, Word, PowerPoint).
Additional Information:
EVERSANA is committed to protecting candidates from recruitment fraud. We never request payment or personal information during the employment process.
Diversity, Equity & Inclusion have always been at the core of EVERSANA’s success. We are an Equal Opportunity Employer, and we believe that the perspectives and experiences of all employees contribute to our innovation and growth.
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