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:
- Medical Physician 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 skills (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).