Physician

The Project Physician tasks may include:Contribute to writing and reviewing of study related documents such as: protocols, protocol amendments, informed consent forms, statistical analysis plans, clinical study reports, and other similar documentsContribute to writing and reviewing medical monitoring plans and other plans for clinical trials, internal or between Otsuka Pharmaceutical Development & Commercialization, Inc. and a CROServe as the primary medical contact for assigned trialProvide oversight of medical monitoring activities and medical surveillance activities of CROParticipate in the evaluation and oversight of clinical trial safety surveillance activitiesContributes to the review of draft and final clinical trial tables and listingsContributes to the review of draft and final clinical study reportsParticipates in the analysis of study data and in post-hoc analysesParticipates and contributes to the designated product Safety Governance meetings and other routine interactions with OPDC PharmacovigilanceReviews and contributes to product-wide aggregate report documents, e.g., IB, DSUR, PSURs, annual reports and other similar documents as assignedPerforms signaling activities including review of medical/scientific literature, and contribute to safety surveillance process, including the identification of safety observations, emergent safety concerns and new safety signals, and ensure prompt assessment and communication of confirmed safety signalsActive contribution to internal and external forums (e.g., DMC, Advisory Boards)Develops and implement Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategies (REMS)Contributes to product label development, scientific regulatory responses, coding review and approval.Contributes to oversight and provides guidance to medical review of individual case safety reports (ICSRs) for investigational and marketed productsContributes to scientific and medical publications, posters and presentations as needed

Requirements:12+ month contract 3-5 Years experience in Drug Safety with Similar TaskExperience with single case unblindingKnowledge with early development activities and documentsMust be an MD or DO