Global Safety Lead

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 Youll 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 CRGs 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. Youll 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 tomorrows breakthrough.