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Medical reviewer (ICSR) Vacancies at ClinChoice · Bangalore
About the ClinChoice
ClinChoice, located in Bangalore Urban, Karnataka, India, is a prominent player in the healthcare and pharmaceutical industry. With a commitment to excellence, ClinChoice has established itself as a key player in medical research and clinical services. Founded on principles of innovation, integrity, and inclusivity, ClinChoice fosters a work culture that values its employees’ growth and development.
ClinChoice Vacancies List
Explore exciting opportunities at ClinChoice. We are currently seeking candidates for the following position:
Position Title: Medical Reviewer (ICSR)
Location: Bangalore Urban, Karnataka, India
Job Description
About the Job
As a Medical Reviewer (ICSR) at ClinChoice, you will play a pivotal role in ensuring the safety and compliance of medical data. Your responsibilities will include:
Primary Responsibilities:
- Demonstrate awareness and understanding of relevant GVP modules.
- Conduct medical review of non-serious & serious ICSRs, emphasizing seriousness, expectedness, causality, and narrative quality.
- Experience in medical review of ICSRs from various sources, including Spontaneous, Literature, Regulatory Authority, Solicited, and Clinical Trials.
- Expertise across multiple therapeutic areas, such as Oncology, Respiratory, Immunology, Neuroscience, and Rare diseases.
- Support triage of cases and determine seriousness and relatedness across assigned products.
- Review and verify the appropriate selection of adverse events, assign MedDRA codes, assess labeling, and review narratives.
- Acquire and maintain current knowledge of the product portfolio and safety profiles.
- Contribute to process improvement activities and quality control processes.
- Provide medical guidance to data entry associates and quality reviewers.
- Identify and resolve case issues, coordinating with client therapeutic teams and within the functional team.
- Maintain PV expertise and understanding of international safety regulations and guidelines.
- Ensure timely completion of Medical Review activities in the safety database.
- Provide feedback to case processors and assist in training/mentoring.
- Adapt to different client case processing conventions and multitask as per business needs.
- Perform ad-hoc tasks as advised by the team lead/manager.
Relevant Experience:
- Thorough knowledge of ICH-GCP, relevant GVP modules, 21 CFR guidelines, and other regulatory requirements.
- Training and mentoring skills in GVP concepts & medical aspects.
- Hands-on experience with MS Office applications (Outlook, Excel, Word, PowerPoint).
How to Apply
Interested candidates are invited to apply through Linkedin
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