01 Aug
|
ClinChoice
|
Bengaluru
01 Aug
ClinChoice
Bengaluru
About ClinChoice
ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology to help our partners advance healthcare by accelerating clinical trials with data-driven insights, delivering the best strategies for product registration, and enhancing patient safety through real-world and clinical analysis.
Our global delivery network has expanded to centers and satellite offices in the United States, Mexico, United Kingdom, Armenia, China, Japan, India, and the Philippines to help our customers maintain regulatory compliance locally and globally.
We have forged future-defining partnerships with industry bodies and technology companies to develop cutting-edge solutions that deliver our expertise with quality and precision.
Primary Responsibilities:
Awareness and understanding of relevant GVP modules.
Perform medical review of non-responsible & reliable ICSRs with emphasis on seriousness, expectedness, causality & narrative etc. without missing on quality & compliance.
Experience of medical review of ICSRs received from sources such as Spontaneous, Literature, Regulatory Authority, Solicited and Clinical trials.
Experience across multiple therapeutic areas such as Oncology, Respiratory, Immunology, Neuroscience, Rare diseases etc.
Support triage of cases and determine seriousness and relatedness across products as assigned.
Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labelling and review narrative.
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 medical guidance and expert opinion on the cases to the data entry a
📌 Medical Review Physician Bengaluru
🏢 ClinChoice
📍 Bengaluru