Job Title: Medical Reviewer (ICSRs)
Location: Remote
Department: Pharmacovigilance
About EVERSANA:
At EVERSANA, we are proud to be recognized as a Great Place to Work across the globe. With a team of over 7,000 employees, we are committed to advancing healthcare and improving patient outcomes. We provide innovative commercialization services to the life sciences industry, helping bring next-generation therapies to market. Join us in our mission to make an impact every day!
We embrace diversity and inclusion and are committed to building a culture that celebrates a range of experiences and backgrounds. Our team is driven by a shared passion for improving patient lives and shaping the future of healthcare.
Position Summary:
The Medical Reviewer plays a key role in performing medical reviews, evaluations, and analyses of Individual Case Safety Reports (ICSRs). This position supports pharmacovigilance (PV) efforts, ensuring compliance with safety data, regulatory guidelines, and the medical aspects of PV. As a Medical Reviewer, you will assist clients with safety data, medical evaluations, and ensure compliance with pharmacovigilance legislation.
Key Responsibilities:
Medical Review and Evaluation:
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.
Compose, edit, and review Analyses of Similar Events (AOSE) for expedited cases, adhering to regulatory requirements.
Serve as an internal consultant to the pharmacovigilance case processing teams.
Maintain an in-depth understanding of scientific therapies, drug-induced diseases, and the drug development process, including knowledge of medical devices, vaccines, and related regulatory requirements.
Knowledge and Compliance:
Continuously acquire and maintain knowledge of product portfolios and safety profiles across various therapeutic areas.
Participate in process improvement activities, including the implementation of quality control processes.
Provide timely feedback to case processors on errors and discrepancies identified during case evaluations.
Assist in the training and mentoring of other personnel involved in case processing and medical review.
Stay up to date on industry developments related to medical safety and regulatory changes.
General Expectations:
Travel: <5%
Work Hours: 45 hours per week
This role requires independent performance of responsibilities, meeting deadlines and regulatory timelines.
Qualifications:
Education and Experience:
Medical Degree (MBBS, MD, BDS, MDS) required.
1-2 years of experience in medical review of ICSRs in pharmaceutical, biotech, or medical device settings. CRO experience is highly desirable.
Expertise in regulatory guidelines (FDA, ICH GCP, MHRA, PMDA, EU Clinical Trial Directives, GVP Modules, etc.).
Strong written and verbal communication skills.
Proficiency in MS Office (Outlook, Excel, Word, PowerPoint).
Additional Information:
All information will be kept confidential in accordance with EEO guidelines.
Diversity, Equity & Inclusion are core values at EVERSANA. We are an Equal Opportunity Employer, and our employees come from diverse backgrounds and experiences. We value all identities, including race, gender, age, disability status, veteran status, sexual orientation, religion, and more.
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