C
Medical Reviewer Consultant
Contract type
One-time
Work mode
Remote · Brazil
Experience
Mid-level · 2+ years
Job description
Medical Reviewer role at ClinChoice, a contract position based in Brazil, responsible for medical review of individual case safety reports (ICSRs) in pharmacovigilance. The role ensures quality and compliance with regulatory timelines and safety guidelines.
At a glance
- Employment
- Contract
- Work mode
- Remote · Brazil
- Languages
- Japanese
What you'll do
- Perform medical review of non-serious & serious ICSRs with emphasis on seriousness, expectedness, causality & narrative etc. without missing on quality & compliance
- Medical review of ICSRs received from sources such as Spontaneous, Literature, Regulatory Authority, Solicited and Clinical trials
- 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
- Complete 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
What we're looking for
- MBBS/MD with at least 2 years of experience as Medical Reviewer for ICSRs
- 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)
- Hands on experience with MS Office applications (Outlook, Excel, Word, Power Point etc)
- Must be able to Write and speak Japanese
- Awareness and understanding of relevant GVP modules
- Experience across multiple therapeutic areas such as Oncology, Respiratory, Immunology, Neuroscience, Rare diseases etc
Apply
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.
Key facts
- 1995
- Clinical research and pharmacovigilance services
- Established in 1995
- Provides expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology
- Forged future-defining partnerships with industry bodies and technology companies