EVERSANA Hiring Medical Reviewer – Pune
About EVERSANA
EVERSANA supports 650+ clients worldwide with a team of 7,000+ employees. The company is dedicated to improving patient lives by bringing innovative therapies to market. With a strong emphasis on diversity, inclusion, and expertise, EVERSANA fosters a positive work culture where employees can grow and excel. EVERSANA Hiring Medical Reviewer
Job Role: Medical Reviewer
As a Medical Reviewer, you will be responsible for evaluating Individual Case Safety Reports (ICSRs), ensuring compliance with pharmacovigilance (PV) regulations, and handling medical aspects of clinical trials and post-marketing drug reactions.
Key Responsibilities
- Medical Review & Analysis: Evaluate 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 compliance with global regulatory requirements.
- Consultation & Support: Act as an internal consultant for pharmacovigilance case processing teams.
- Product Knowledge: Stay updated on safety profiles and product portfolios for different therapeutic areas.
- Training & Mentoring: Assist in the training and mentoring of new team members.
- Quality Control: Contribute to process improvements and stay informed about medical safety regulations.
Job Expectations
- Work Hours: 45 hours per week
- Travel Requirement: Less than 5%
Required Qualifications
- Education: MBBS, MD, BDS, or MDS degree.
- Experience: 1-2 years as a Medical Reviewer for ICSRs in the pharmaceutical, biotech, or medical device industry. Experience in a CRO is a plus.
- Regulatory Knowledge: Familiarity with international guidelines such as FDA, ICH GCP, MHRA, PMDA, GVP Modules, and EU Clinical Trial Directive.
- Skills:
- Strong interpersonal, organizational, and communication skills.
- Proficiency in MS Office (Outlook, Excel, Word, PowerPoint).
Why Join EVERSANA?
- Work-Life Balance
- Challenging Projects
- Career Growth Opportunities
- Insurance & Employee Benefits
How to Apply?
This is a verified job with an online application process. Don’t miss this opportunity—apply now! EVERSANA Hiring Medical Reviewer
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