Drug Safety Admin Associate III
Thermo Fisher Scientific

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

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 - To enable 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. As part of our clinical research portfolio, our CorEvitas evidence-based solutions specialize in generating data intelligence and clinical insights needed to bring safe and effective treatments to market. Your objectivity and dedication to patient safety will improve health outcomes that people and communities depend on - now and in the future.

Location/Division Specific Information

Remote/Pharmacovigilance

#CorEvitas

Discover Impactful Work:

Quality and accuracy of reporting Drug Safety events is a critical function within CorEvitas. This role will support the collection, tracking, data management, adjudication and reporting of adverse events reported by sites. Quality Control (QC) of the data will be achieved in accordance with Company SOP's, and relevant regulatory standards.

A day in the Life:

Support timely and accurate Drug Safety reporting for critical daily functions including: AE surveillance, intake, and triage while ensuring adherence to department safety reporting plans.

• Demonstrate working familiarity with SOPs, work instructions and key references applicable to CorEvitas's Drug Safety operations (e.g. site manuals, questionnaires, report plans, templates).

• Demonstrate proficiency with standard tools and software systems (and their intended functionality) used to support core Drug Safety functions and reporting deliverables for a variety of end users.

• Support creation of electronic backup files and adjudication packets for reported adverse events.

• Provide data entry and TAE quesionnaire transfer support for incoming Targeted Adverse Events to ensure all events are reported on the proper questionnaires per registry reporting guidelines.

• Provide support for Drug Safety data migration planning, implementation activities, as assigned and participate in departmental strategic planning, problem solving, and quality improvement initiatives.

• Provide processing support for a range of contracted, safety-related deliverables (e.g. adverse event listings, QC and reconciliation reporting).

• Participate in workgroup and team meetings and ongoing professional training or education appropriate to role, as assigned as assigned

• Other duties as assigned (temporary or permanent, based on company needs).

Keys to Success:

Education

• Bachelors Degree (or relevant alternate concentration)

Experience

• Entry Level

• Completion of GCP, MedDRA, and other role-specific training programs, as assigned.

Knowledge, Skills, Abilities

• Must be highly organized and detail-oriented, with excellent time management skills.

• Strong written and verbal communication skills.

• Proficiency in MS Office: Word, PowerPoint, Excel, Access, and MS Project.

• Ability to work independently or part of a team.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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