About the role
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).
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