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Head of Drug Safety
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$150
- Based on its unique ability to elucidate regulatory regions of the genome, our Client aims to develop medicines that provide a profound benefit for patients with diseases that have eluded other genomics-based approaches.
- Reporting to the Chief Medical Officer, the Head of Drug Safety will be responsible for leading the pharmacovigilance function, providing leadership and clinical support to drug safety data management and interpretation and risk management activities for the company, including oversight of clinical trial Serious Adverse Event (SAE) processing and safety data analysis to support signal detection and risk/benefit profile evaluation.
- Manage all aspects of Drug Safety and Pharmacovigilance, including leadership of safety data review, signal detection, risk communication including safety information updates, and mitigation of potential risks
- Provide medical and drug safety expertise to enable decision-making based on ongoing risk-benefit assessment, clinical trial data interpretation, and medical review of individual case reports of serious adverse events
- Proactively recommend and plan for future development of Drug Safety and Pharmacovigilance to enable regulatory filings and commercialization, including acquiring QPPV support and the participation in creating Risk Management Plans and a Pharmacovigilance System Master File
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