Medical Director M-SERM

Work Schedule

Environmental Conditions

Job Description

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.