Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
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).
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General Support:
Ensures tasks delegated to pharmacovigilance 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. 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 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. Contributes to departmental process improvement initiatives.
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
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 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)
Medical Director level requires:
- Clinical experience in treating patients in the specialty or sub-specialty associated with the applicants training(comparable to 2 years) and one of the following:
- 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).
Qualified candidates should have a background as a formally trained oncologist and/or hematologist with clinical experience.
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-specialties
- Excellent interpersonal skills, influencing and team building skills
- Understanding of 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 within pharmacovigilance
- Strong, well supported decision-making, problem solving, organizational skills and analytical skills
- Excellent oral and written communication skills
- Working knowledge of relevant safety databases (e.g. MedDRA)
- Flexibility to travel domestically and internationally for short periods
- Ability to work independently, analyze work with attention to detail, process and prioritize sensitive complex information
- Proficiency in basic computer productivity applications (e.g. word processor, spreadsheets and presentations)
- Fluent in spoken and written English
Working Conditions and Environment:
- Work is performed in an office environment with exposure to electrical office equipment.
- Occasional drives to site locations with occasional travel both domestic and international.
Physical Requirements:
- Frequently stationary for 6-8 hours per day.
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
- Frequent mobility required.
- Occasional crouching, stooping, bending and twisting of upper body and neck.
- Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
- Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
- Frequently interacts with others to obtain or relate information to diverse groups.
- Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration.
- Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
- Regular and consistent attendance.