Senior Principal Scientist, Drug Safety

·         Engage directly in product development activities via core membership on Product Development Teams and chairmanship of the Risk Management and Safety Team, and other related sub-team participation, for assigned products.  This may include participation in internal and joint internal/external research project teams relevant to the development of new compounds and the further study of marketed compounds.

·         Partners with clinical development to ensure that clinical programs will support robust safety assessment of investigational compounds. Works with Clinical Research to develop the benefit-risk evaluation in aggregate safety reports.

·         The CSRM Physician works closely with cross-functional team members including those from clinical development, epidemiology, regulatory affairs, statistics, and manufacturing to manage safety topics under evaluation to ensure efforts are aligned to meet global pharmacovigilance and risk management strategies for assigned products.

·         Duties include all aspects of safety data evaluation, including assessing safety from multiple sources, e.g., clinical trials, literature and post-approval use and ensuring completeness of safety information in company core data sheets.

·         Accountable for scientific strategy for safety related documents (e.g., CTD components, Risk Management Plans and Periodic Safety Update Reports) and for ensuring that the safety sections of Company product circulars are medically and scientifically appropriate.

·         Responsible for safety surveillance activities for assigned products such as aggregate clinical trial data analysis and post approval safety signaling reviews, using medical judgment in review of aggregate data and individual cases. Collaborates with CSRM Associate in the oversight of safety surveillance activities for assigned products.

·         Responsible for risk management activities such as contributing to recommendations for pharmacovigilance actions, making recommendations for labeling, and developing the Risk Management Plans, pharmacovigilance strategies and risk minimization activities in collaboration with CSRM Associate.

·         Oversees the review and approval of product labeling files stored in the safety database and demonstrates a working knowledge of MedDRA.

·         The CSRM Physician prepares safety summaries and analyses of safety related data for regulatory documents, aggregate reports, and summaries in support of regulatory filings and may supervise the activities of CSRM medical associates in the execution of safety data analysis and authoring of regulatory documents.

·         Participates in the development, implementation and evaluation of standards, processes, metrics, and other department initiatives.