Work Schedule
Standard Office Hours (40/wk)
Environmental Conditions
Office
Join us as a Medical Director M-SERM - And lead our efforts in medical safety evaluation and risk management.
What You'll Do:
- 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.
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
- 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.
Why Join Us
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You'll work in an environment where collaboration and development are part of the everyday experience – and where your contributions truly make a difference.
Apply today to help us deliver tomorrow's breakthrough.
