Job Description

　　Summarized Purpose:

　　Provides medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed. Attends and presents at investigator and sponsor meetings, provides medical consultation to clients, investigators and project team members and supports business development activities. Provides medical review and analysis for clinical trial serious adverse events, marketed products ICSR and periodic safety reports ( e.g. PBRER, PSUR, DSUR) as well as other client deliverables (e.g. labeling reconciliation documents, CTD modules, REMS, RMP and CSR).

　　Essential Functions and Other Job Information:

　　Manages all medical aspects of contracted tasks across the pharmaceutical product life-cycle.

　　General Support:

　　Ensures tasks delegated to PVG are properly executed. Adheres to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues. Adheres to client SOPs/directives and project specific WPDs for assigned projects. Adheres to PPD's corporate policies and SOPs/WPDs.Provides medical consultation to team members and answer all study related medical questions. Communicates clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately.Provides therapeutic training and protocol training on assigned studies, as requested.Assists in writing (interpretation of safety and efficacy data) and/or review of CSR, IND/NDA report, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, etc. to ensure that the medical content is accurate and complete.

　　Clinical Trial Support:

　　Monitors all safety variables (AE, laboratory abnormalities, changes in patient medical status, evaluation of prescribed concomitant medication for protocol restrictions, and un-blinding requests) of clinical studies.Discusses all medical concerns with principal investigators and clients (e.g. discussion regarding interpretation of inclusion/exclusion criteria) raised during the course of a study, using proper medical judgment in the interpretation and decision making with regard to clinical situations as they relate to the investigational study.Provides medical review of adverse events of special interest, serious adverse events and clinical outcomes events reported by study sites.Performs data review as specified in the client contract and data validation manual including review of coding listings and/or full safety data to assess for potential safety concerns.

　　Marketed Products Support:

　　Manages signal detection activities, scientifically reviews aggregate reports, contributes to label updates, supports dossier maintenance and risk management activities.Medically reviews adverse event and serious adverse event data from all sources (solicited, spontaneous, literature, etc) as contracted

　　Education and Experience:

　　MD or equivalent required. Active medical licensure preferred. Candidates should have at least one of the following:Clinical experience in treating patients in the specialty or sub-specialty associated with the applicants training (comparable to 2 years); OrSuitable clinical trial experience in a Contract Research Organization, pharmaceutical company or as a principal investigator (comparable to 1-2 years) in the industry; OrDirect experience in safety/Pharmacovigilance (comparable to 2 years).

　　Additional industry(CRO/Pharma) experience is required for Medical Director and Senior Medical Director levels.

　　In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

　　Knowledge, Skills and Abilities:

　　Therapeutic expertise across one or more medical specialty or sub-specialtiesStrong decision-making, problem solving, organizational skills and analytical skillsExcellent oral and written communication skillsWorking knowledge of relevant safety databases (e.g. Medra)Flexibility to travel domestically and internationallyAbility to work independently, analyze work with attention to detail, process and prioritize sensitive complex informationProficiency in basic computer applicationsFluent in spoken and written EnglishExcellent interpersonal, influencing and team building skillsUnderstanding guidelines (FDA, ICH, EMA and GCP)Working knowledge of biostatistics, data management, and clinical operations proceduresAbility to act as a mentor/trainer to other staff