Medical Reviewer (ICSR) Opportunities at ClinChoice


Advertisements

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.

Advertisements

ClinChoice Vacancies List

Explore exciting opportunities at ClinChoice. We are currently seeking candidates for the following position:

Position Title: Medical Reviewer (ICSR)

Advertisements

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:

Advertisements

Primary Responsibilities:

  1. Demonstrate awareness and understanding of relevant GVP modules.
  2. Conduct medical review of non-serious & serious ICSRs, emphasizing seriousness, expectedness, causality, and narrative quality.
  3. Experience in medical review of ICSRs from various sources, including Spontaneous, Literature, Regulatory Authority, Solicited, and Clinical Trials.
  4. Expertise across multiple therapeutic areas, such as Oncology, Respiratory, Immunology, Neuroscience, and Rare diseases.
  5. Support triage of cases and determine seriousness and relatedness across assigned products.
  6. Review and verify the appropriate selection of adverse events, assign MedDRA codes, assess labeling, and review narratives.
  7. Acquire and maintain current knowledge of the product portfolio and safety profiles.
  8. Contribute to process improvement activities and quality control processes.
  9. Provide medical guidance to data entry associates and quality reviewers.
  10. Identify and resolve case issues, coordinating with client therapeutic teams and within the functional team.
  11. Maintain PV expertise and understanding of international safety regulations and guidelines.
  12. Ensure timely completion of Medical Review activities in the safety database.
  13. Provide feedback to case processors and assist in training/mentoring.
  14. Adapt to different client case processing conventions and multitask as per business needs.
  15. Perform ad-hoc tasks as advised by the team lead/manager.
Medical Reviewer (ICSR) Opportunities at ClinChoice

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 

Leave a Comment