Medical Reviewer
1 week ago
We are seeking a highly skilled Medical Reviewer to join our team at EVERSANA. As a Medical Reviewer, you will play a critical role in ensuring the quality and accuracy of Individual Case Safety Reports (ICSRs) and assisting clients with safety data and compliance with pharmacovigilance legislation and guidance.
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 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.
- MBBS/MD/BDS/MDS degree.
- 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.).
We are an Equal Opportunity Employer and value diversity in backgrounds and experiences. If you are passionate about improving patient lives and leading innovation within the healthcare industry, we encourage you to apply for this exciting opportunity.
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Pune H.O, India EVERSANA Full timeAt EVERSANA, we are proud to be certified as a Great Place to Work across the globe. We’re fueled by our vision to create a healthier world. How? Our global team of more than 7,000 employees is committed to creating and delivering next-generation commercialization services to the life sciences industry. We are grounded in our cultural beliefs and serve...
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2 weeks ago
Pune, Maharashtra, India EVERSANA Full timeJob Title: Medical ReviewerJob Summary:We are seeking a highly skilled Medical Reviewer to join our team at EVERSANA. As a Medical Reviewer, you will be responsible for performing medical review, evaluation, and analysis of Individual Case Safety Reports (ICSRs) to assist clients with safety data, compliance with pharmacovigilance legislation and guidance,...
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Medical Reviewer
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Pune, Maharashtra, India EVERSANA Full timeJob Title: Medical ReviewerWe are seeking a highly skilled Medical Reviewer to join our team at EVERSANA. As a Medical Reviewer, you will play a critical role in ensuring the safety and efficacy of our clients' products.Key Responsibilities:Perform medical review of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) to ensure...
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Pune, India EVERSANA Full timeJob Description JOB DESCRIPTION:The most important aspect of this position is to perform medical review, evaluation, and analysis of Individual Case Safety Reports (ICSRs), assisting clients with the safety data, compliance with pharmacovigilance (PV) legislation and guidance, and all medical aspects of PV.KEY RESPONSIBILITIES FOR THIS ROLE:Perform medical...
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Medical Content And Review Specialist
1 month ago
Pune H.O, India EVERSANA Full timeAt EVERSANA, we are proud to be certified as a Great Place to Work across the globe. We’re fueled by our vision to create a healthier world. How? Our global team of more than 7,000 employees is committed to creating and delivering next-generation commercialization services to the life sciences industry. We are grounded in our cultural beliefs and serve...
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2 weeks ago
pune, India EVERSANA Full timeAt EVERSANA, we are proud to be certified as a Great Place to Work across the globe. We’re fueled by our vision to create a healthier world. How? Our global team of more than 7,000 employees is committed to creating and delivering next-generation commercialization services to the life sciences industry. We are grounded in our cultural beliefs and serve...
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Pune, India EVERSANA Full timeAt EVERSANA, we are proud to be certified as a Great Place to Work across the globe. We’re fueled by our vision to create a healthier world. How? Our global team of more than 7,000 employees is committed to creating and delivering next-generation commercialization services to the life sciences industry. We are grounded in our cultural beliefs and...
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Medical Reviewer
1 month ago
pune, India EVERSANA Full timeAt EVERSANA, we are proud to be certified as a Great Place to Work across the globe. We’re fueled by our vision to create a healthier world. How? Our global team of more than 7,000 employees is committed to creating and delivering next-generation commercialization services to the life sciences industry. We are grounded in our cultural beliefs and serve...
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Medical Reviewer
1 month ago
Pune, India EVERSANA Full timeAt EVERSANA, we are proud to be certified as a Great Place to Work across the globe. We’re fueled by our vision to create a healthier world. How? Our global team of more than 7,000 employees is committed to creating and delivering next-generation commercialization services to the life sciences industry. We are grounded in our cultural beliefs and serve...
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6 days ago
pune, India EVERSANA Full timeAt EVERSANA, we are proud to be certified as a Great Place to Work across the globe. We’re fueled by our vision to create a healthier world. How? Our global team of more than 7,000 employees is committed to creating and delivering next-generation commercialization services to the life sciences industry. We are grounded in our cultural beliefs and serve...
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Medical Reviewer
1 month ago
Pune, India EVERSANA Full timeAt EVERSANA, we are proud to be certified as a Great Place to Work across the globe. We’re fueled by our vision to create a healthier world. How? Our global team of more than 7,000 employees is committed to creating and delivering next-generation commercialization services to the life sciences industry. We are grounded in our cultural beliefs and serve...
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Pune, India EVERSANA Full timeAt EVERSANA, we are proud to be certified as a Great Place to Work across the globe. We’re fueled by our vision to create a healthier world. How? Our global team of more than 7,000 employees is committed to creating and delivering next-generation commercialization services to the life sciences industry. We are grounded in our cultural beliefs and serve...
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Medical Reviewer
1 month ago
Pune, India EVERSANA Full timeAt EVERSANA, we are proud to be certified as a Great Place to Work across the globe. We’re fueled by our vision to create a healthier world. How? Our global team of more than 7,000 employees is committed to creating and delivering next-generation commercialization services to the life sciences industry. We are grounded in our cultural beliefs and serve...
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Medical Reviewer
1 month ago
pune, India EVERSANA Full timeAt EVERSANA, we are proud to be certified as a Great Place to Work across the globe. We’re fueled by our vision to create a healthier world. How? Our global team of more than 7,000 employees is committed to creating and delivering next-generation commercialization services to the life sciences industry. We are grounded in our cultural beliefs and serve...
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Medical Reviewer
1 month ago
Pune, India EVERSANA Full timeAt EVERSANA, we are proud to be certified as a Great Place to Work across the globe. We’re fueled by our vision to create a healthier world. How? Our global team of more than 7,000 employees is committed to creating and delivering next-generation commercialization services to the life sciences industry. We are grounded in our cultural beliefs and serve...
