Medical Reviewer
1 month ago
Job Summary:
At EVERSANA, we are committed to creating a healthier world by delivering next-generation commercialization services to the life sciences industry. As a Medical Reviewer - Pharmacovigilance Specialist, you will play a critical role in ensuring the safety of patients by performing medical review, evaluation, and analysis of Individual Case Safety Reports (ICSRs).
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 the stipulated time to comply with service level agreements and regulatory timelines.
- Compose, edit, and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements.
- Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported.
- Deep understanding of the scientific basis for therapies and drug-induced diseases. Knowledge of medical device, vaccines and drug development process;
- Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas.
- Involve in process improvement activities such as implementation of quality control process.
- Provide timely feedback to case processors on the errors/discrepancies noted.
- Assist in training/mentoring of other case processing/medical review personnel as necessitated.
- Participate in organizational activities to meet objectives suitable for the role/area of expertise.
- Maintain awareness of medical-safety-regulatory industry developments.
Requirements:
- MBBS/MD/BDS/MDS
- 1-2 years of experience as Medical Reviewer for ICSRs in pharmaceutical, biotech, medical device. CRO experience highly desirable.
- Regulatory guidelines expertise: knowledge of international guidelines and country specific regulatory requirements (FDA, ICH GCP, MHRA, Pharmaceuticals and Medical Devices Agency (PMDA), GVP Modules; respective EU Clinical Trial Directive etc.)
- Excellent interpersonal and organizational skills. Excellent written and verbal communication skills.
- Must have hands on experience with MS Office applications (Outlook, Excel, Word, PowerPoint, etc.).
Additional Information:
EVERSANA is an Equal Opportunity Employer and is committed to creating a diverse and inclusive workplace. We respect the personal rights of all candidates looking to explore careers at EVERSANA.
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