Job Description

　　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, Signal detection reports and CSR).

　　Maintains understanding of methods for recording time spent on project and administrative tasks, expense submissions and travel.

　　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 project/study

　　related medical questions. Communicates clearly with associates and clients,

　　maintaining an open line of communication to ensure all procedures are followed

　　appropriately.

　　Provides safety reporting training on assigned projects/studies, as requested.

　　Medically reviews adverse event and serious adverse event data from all sources

　　(solicited, spontaneous, literature, etc) as contracted.

　　Provides medical review of adverse events of special interest, serious adverse

　　events and clinical outcomes events reported in Clinical Trials.

　　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.

　　Assists in writing (interpretation of safety 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.

　　Manages signal detection activities, scientifically reviews periodic safety reports,

　　contributes to label updates, supports dossier maintenance and risk management activities.

　　Develops solutions to highly complex and unique issues that impact and address future concepts, products or technologies.

　　Having broad expertise or unique knowledge, uses skills to contribute to

　　development of company objectives and principles and to achieve goals in creative

　　and effective ways. Normally requires nomination and management committee

　　review and approval at this level.

　　Exercises wide latitude in determining objectives and approaches to critical

　　assignments. Complete latitude for independent judgment in methods, techniques

　　and evaluation criteria for obtaining results.

　　Serves as a consultant and spokesperson for the functional area or as an external

　　spokesperson for the organization on highly significant matters. Creates formal networks with key decision makers.

　　Qualifications:

　　Education and Experience:

　　MD or equivalent required. History of an active medical license highly preferred. Candidates should have at least one of the following:

　　• Clinical experience in having direct responsibility for diagnostic and treatment decisions (comparable to 2 years);

　　Or

　　• Direct experience in medical review and assessment of safety information/Pharmacovigilance

　　(comparable to 3 years).

　　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:

　　Fluent in spoken and written English

　　General medical knowledge of diagnostic and therapeutic approaches across multiple specialties.

　　Therapeutic expertise across one or more medical speciality or sub-specialities preferred.

　　Strong decision-making, problem solving, organizational skills and analytical skills

　　Excellent oral and written communication skills

　　Excellent interpersonal skills

　　Working knowledge of guidelines (FDA, ICH, EMA and GCP)

　　Understanding of basic biostatistics, data management, and clinical operations procedures

　　Excellent organizational skills

　　Ability to work independently, analyze work with attention to detail, process and prioritize sensitive

　　complex information

　　Working knowledge of the drug development process and thorough understanding of guidelines for

　　marketing authorization submissions and international guidelines for conduct of clinical studies

　　Working knowledge of clinical program and study design, relevant endpoints, safety considerations,

　　and current regulatory and commercial landscape.

　　Working knowledge of marketed products pharmacovigilance regulations

　　Working knowledge of Drug Safety Dictionaries (e.g. MedDRA)

　　Working knowledge of relevant safety databases (e.g. ARGUS, ARISg)

　　Ability to act as a mentor/trainer to entry level staff within the Pharmacovigilance Department

　　Flexibility to travel domestically and internationally

　　Proficiency in basic computer applications

　　Ability to serve as the group liaison with other PPD groups and clients

　　Management Role:

　　No management responsibility