Vacancy Description
- 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 c...
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