Provides medical oversight of clinical trials to ensure company SOPs, client directives, good clinicalpractice, and regulatory requirements are followed.
Attends and presents at investigator and sponsormeetings, provides medical consultation to clients, investigators and project team members and supportsbusiness development activities.
Provides medical review and analysis for clinical trial serious adverse events, marketed products ICSR andperiodic safety reports ( e.
g. PBRER, PSUR, DSUR) as well as other client deliverables (e.g. labelingreconciliation documents, CTD modules, REMS, RMP and CSR).
Essential Functions and Other Job Information : Manages all medical aspects of contracted tasks across the pharmaceutical productlife-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.
Qualifications : Education and Experience : MD or equivalent required. Active medical licensure preferred. Candidates should have at least one of thefollowing :
Clinical experience in treating patients in the speciality or sub-speciality associated with the applicants training (comparable to 2 years); Or
Suitable clinical trial experience in a Contract Research Organization, pharmaceutical company or as a principal investigator (comparable to 1-
2 years) in the industry; Or
Direct experience in safety / Pharmacovigilance (comparable to 2 years).
Knowledge, Skills and Abilities :
Therapeutic expertise across one or more medical speciality or sub-specialities
Strong decision-making, problem solving, organizational skills and analytical skills
Excellent oral and written communication skills
Working knowledge of relevant safety databases (e.g. Medra)
Flexibility to travel domestically and internationally
Ability to work independently, analyze work with attention to detail, process and prioritize sensitive complex information
Proficiency in basic computer applications
Fluent in spoken and written English
Excellent interpersonal, influencing and team building skills
Understanding guidelines (FDA, ICH, EMA and GCP)
Working knowledge of biostatistics, data management, and clinical operations procedures
Ability to act as a mentor / trainer to other staff