- Performs medical assessment activities related to drug safety pharmacovigilance for the assigned therapeutic area (pain & inflammation)
- Perform single case medical assessment, including the determination of seriousness, expectedness, listedness, labeldness and causality of adverse events in compliance with current regulations, internal and external guidance documents, SOPs, Safety Job Aids, the Argus User Reference Guide and case processing/coding conventions
- Maintain the timely submission of expedited reports
- Support the achievement of the TA's case processing performance timelines
- Identify cases that meet SUSAR reporting criteria, prepare the SUSAR narrative, perform risk assessment, initiate the unblinding process (as appropriate), and make the report available for distribution
- Identify and evaluate safety signals based on individual cases and cumulative data assessment and by using other signal detection systems
- Provide data-driven decisions and communicate these findings proactively and effectively to the key stakeholders
- Provide medical safety input as appropriate to Clinical Development Teams regarding expectedness/listedness/labeledness, causality and data reconciliation
- As appropriate, provide medical safety input, and review or draft sections of response documents to health authority inquiries
- Candidates must be MD's (US Board certification NOT required)
- Industry experience and past drug safety experience is required
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