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 centres 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.
Job Description
Primary Responsibilities:
* Awareness and understanding of relevant GVP modules.
* Perform medical review of non-serious & serious 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 associates and quality reviewers to help resolve queries.
* Identify and resolve case issues, coordinate with client therapeutic teams and within functional team and manage as appropriate.
* Maintain PV expertise, and understanding of international safety regulations and guidelines.
* Responsible for completing the MR activities in the safety database within the stipulated time to comply with service level agreements and regulatory timelines.
* Provide timely feedback to case processors on the errors/ discrepancies noted.
* Assist in training/mentoring of other case processing/medical review personnel as necessitated.
* Adapt to different client case processing conventions and multi-task as per business needs.
* Perform ad-hoc tasks as advised by the team lead/manager with quality and compliance as per project requirement.
* Participate in organizational activities to meet objectives suitable for the role/area of expertise.
Candidate Profile
Candidate Requirements:
* Should be a MBBS/MD with at least 2 years of experience as Medical Reviewer for ICSRs.
* Must possess thorough knowledge of ICH-GCP, relevant GVP module, 21 CFR guidelines and other regulatory requirements.
* Training and mentoring skill (GVP concepts & medical aspects such as disease condition, product portfolio etc)
* Must have hands on experience with MS Office applications (Outlook, Excel, Word, Power Point etc)
* Must be able to Write and speak Japanese.
* Dynamic working hours.
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