Job Description

Work Schedule Standard (Mon-Fri)
Environmental Conditions Office

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
Our detailed, goal-oriented Pharmacovigilance colleagues manage the safety profile of new drugs in clinical trials, oversee case-processing activities through all phases of development and perform regulatory reporting and medical monitoring.
As part of your work with beginning-to-end trial experience, you will expand your knowledge and experience working on clinical trials through every stage of drug development. This includes management and oversight of all contracted services.
Discover Impactful Work:
Discover Impactful Work:Assists in the management and ongoing evaluation of medical projects for one or more programs in collaboration with management and other stakeholders to ensure consistency, alignment, and compliance of internal processes as well as optimal performance and issue resolution throughout project lifecycle.
A day in the Life:

• Coordinates and reviews safety data, utilizing line listings, company dashboard(s) and/or other visualization tools. Reviews data for safety trends, coding consistencies, and potential follow up with investigator sites. Identifies potential issues and resolves or escalates as appropriate
• Reviews safety data and may provide summations for safety review meetings. May review designated sections of aggregate reports.
• May help to create/review safety and medical management plan(s) on studies (as applicable) and ensures that the processes included in plan documents are reflective of the contract and services requested.
• May help Manage routine project implementation, forecasting and coordination, including review of metrics and budget considerations.
• Monitors the status of the data review and escalates any delays and/or risks to all stakeholders, including study leads.
• May present at business development, client, and investigator meetings and participate in strategy/business development calls.
• Resolves complex problems through in-depth evaluation of various factors and offers solutions.
• May serve as the primary point of contact for clinical/data management project teams.
• May assist management in training and mentoring.

Keys to Success:
Education

• Bachelors degree in Nursing or related Health Sciences (Physician's Assistant) or licensed RN

Experience

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years), to include 2+ years clinical safety experience (clinical research monitoring, or pharmacovigilance or combination of clinical research monitoring and pharmacovigilance)

Knowledge, Skills, Abilities

• Knowledge of GCPs for medical oversight of clinical trials and SAE processing
• Knowledge of drug development and safety reporting
• Knowledge of safety data trending to include coding
• Working knowledge of biostatistics, data management and clinical procedures
• Strong problem solving and critical thinking skills
• Good oral and written communication skills
• Good Strong attention to detail
• Ability to work in a collaborative team environment
• Ability to maintain a positive and professional demeanor in challenging circumstances

Work Environment
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary for typical working hours.
• Ability to use and learn standard office equipment and technology with proficiency.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
• May require travel. (Recruiter will provide more details.)

Skills Required