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Clinical Pharmacovigilance/Drug Safety

tunities located in: NY, NJ, PA, MA, NC   Summary Responsible for providing medical and clinical insight and guidance through clinical trials for pharmaceuticals. Primary responsibilities Provide medical and clinical guidance to managers before, throughout, and following clinical trials. Maintain consistency of safety assessments. Perform a variety of safety assessments. Serve in cross-functional teams as a medical and scientific representative. Ensure regulatory compliance and safety throughout trial. Submit periodic reports to the Food and Drug Administration. Ensure that medical and causality assessments of all clinical and post-marketing adverse event fillings to foreign regulatory authorities are consistent with company policies, as well as the respective foreign regulatory requirements. Address labeling concerns and updates. Interpret regulatory mandates. Assist with internal and external drug safety audits Create company data sheets. Remediate any pharmacovigilance deficiencies found during regulatory or internal audits. Act as medical expert during product development. Ensure subject safety during clinical studies. Establish and maintain consistency of safety assessments within the US and outside the US. Identify the correct actions and facilitate, support and implement them as appropriate. Review performance metric data and clarify inconsistencies and trends.