Global Safety Lead

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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:

• Maintain understanding of methods for recording time spent on project and administrative tasks, expense submissions and travel.
• Ensure tasks delegated to PV are properly executed. Adhere to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues. Adhere to client SOPs/directives and project specific WPDs for assigned projects. Adhere to CRG’s corporate policies and SOPs/WPDs.
• Provide medical consultation to team members and answer all project/study related medical questions. Communicate clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately.
• Provide safety reporting training on assigned projects/studies, as requested.
• Medically reviews adverse events and serious adverse event data from all sources (solicited, spontaneous, literature, etc) as contracted.
• Provide medical review of adverse events of special interest, serious adverse events and clinical outcomes events reported in Clinical Trials.
• Perform 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.
• Assist 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.
• Manage signal detection activities, scientifically review 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 is 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 specialties or sub-specialties 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 a group liaison with other CRG 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.