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Medical Reviewer

1-2 years
Not Disclosed
10 Dec. 12, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Company Overview:

At EVERSANA, we are proud to be recognized as a Great Place to Work globally. Our mission is to create a healthier world, and we achieve this through our team of over 7,000 employees dedicated to delivering next-generation commercialization services in the life sciences industry. Serving more than 650 clients, including innovative biotech startups and established pharmaceutical companies, we bring life-changing therapies to market and support the patients who rely on them. Together, we make an impact every day.

We are committed to fostering diversity and inclusivity in our growing organization. Improving patient lives is our priority, and we believe that people from all walks of life are essential to shaping the future of healthcare and life sciences. We encourage team members who care deeply about our mission and our patients to join us. At EVERSANA, we value the unique contributions of each individual, and together we create an environment that embraces our cultural beliefs.


Position: Medical Reviewer - Pharmacovigilance
Location: [Insert Location]
Job Type: Full-time


Job Description:

The Medical Reviewer will perform the medical review, evaluation, and analysis of Individual Case Safety Reports (ICSRs), assisting clients with safety data, compliance with pharmacovigilance (PV) legislation, and medical aspects of PV.


Key Responsibilities:

  • Medical Review: Review trial-related Adverse Events (AEs) and post-marketing Adverse Drug Reactions (ADRs), including narrative content, queries, coding, expectedness, seriousness, causality, and summary to meet service level agreements and regulatory timelines.
  • Analysis: Compose, edit, and medically review Analyses of Similar Events (AOSE) for expedited cases as per regulatory requirements.
  • Consultation: Provide expertise and consultation to pharmacovigilance case processing teams on supported projects.
  • Scientific Knowledge: Maintain a deep understanding of therapies, drug-induced diseases, medical devices, vaccines, and the drug development process.
  • Safety Profiles: Acquire and maintain current knowledge of product portfolios and safety profiles across therapeutic areas.
  • Quality Control: Participate in process improvement activities, implementing quality control processes.
  • Training and Mentoring: Assist in training and mentoring case processing and medical review personnel.
  • Industry Awareness: Stay updated on medical safety and regulatory industry developments.

Job Expectations:

  • Travel: <5% travel.
  • Work Hours: 45 hours per week.
  • Additional Duties: Perform other duties as assigned, with flexibility in the scope of responsibilities.

Education & Experience:

  • Required: MBBS/MD/BDS/MDS degree.
  • Experience: 1-2 years of experience as a Medical Reviewer for ICSRs in pharmaceutical, biotech, or medical device sectors. CRO experience is highly desirable.
  • Regulatory Knowledge: Strong understanding of international regulatory guidelines (e.g., FDA, ICH GCP, MHRA, PMDA, GVP, EU Clinical Trial Directive).
  • Skills: Excellent interpersonal, organizational, written, and verbal communication skills. Proficiency in MS Office (Outlook, Excel, Word, PowerPoint).

Fraud Prevention Notice:

Be cautious of fraudulent job offers misrepresenting EVERSANA. We will never ask for personal information or payment during the hiring process. If you encounter suspicious offers, please report them immediately.


Diversity, Equity, and Inclusion:

EVERSANA is proud to be an Equal Opportunity Employer. We believe diversity in our workforce is essential to our success, and we actively cultivate an inclusive environment where all perspectives are valued. Diversity encompasses race, gender, age, disability, veteran status, sexual orientation, religion, and more. Inclusion is everyone’s responsibility, and all viewpoints are critical to improving the lives of patients and leading healthcare innovation.