Safety Specialist

Thermo Fisher Scientific

2 years years

Preffered by Company

Remote

Not Disclosed May 13, 2024

Job Description

Job Type: Full Time Education: B.Pharm/M.Pharm/PharmD Skills: ICSR Case Processing

Safety Specialist

Job Information

Available Locations: 13 locations
Job ID: R-01236939
Job Type: Full-time
Category: Clinical Research
Remote: Fully Remote

Job Description

At Thermo Fisher Scientific, we strive to make a positive global impact through meaningful work. Join us in our mission to enable our customers to make the world healthier, cleaner, and safer. We support our teams in achieving individual career goals while advancing science through research, development, and delivery of life-changing therapies. Our PPD clinical research portfolio spans laboratory, digital, and decentralized clinical trial services, as well as post-approval support. Your dedication to quality and accuracy will improve health outcomes for people and communities worldwide.

Discover Impactful Work

For over 25 years, PPD has provided comprehensive pharmacovigilance (PV) services and currently employs over 1300 PV professionals globally. We are expanding our “spoke” locations to deliver local PV services. As a Safety Specialist, you will be responsible for performing daily PV activities within a regulated environment, including:

Monitoring, collecting, translating, disseminating, and tracking safety information
Serving as a regulatory authority contact point
Supporting global PV operations with data entry, coding, adverse event assessment, follow-up, tracking reports, and regulatory reporting activities
Collaborating with project team members, client contacts, reporters, and third-party vendors
Assisting in preparing departmental and project-specific procedures and processes
Preparing for and attending meetings, audits, and regulatory authority inspections

This role offers an opportunity to advance your PV career while gaining exposure to both post-approval and clinical trial settings.

A Day in the Life

Perform daily PV activities
Participate in on-call duties for 24-hour coverage for regulatory authority calls
Review regulatory/pharmacovigilance publications and information sources to stay updated on current regulations, practices, and procedures
Review cases for quality, consistency, and accuracy
Prepare and maintain regulatory safety reports
Assist with routine project implementation and coordination, including presentations at client meetings and review of metrics and project budgets
Mentor less experienced staff

Education

Bachelor’s degree or equivalent formal academic/vocational qualification
Previous experience providing the knowledge, skills, and abilities to perform the job (comparable to 2+ years)
In some cases, a combination of education, training, and/or directly related experience will be considered sufficient

Knowledge, Skills, Abilities

Strong critical thinking and problem-solving skills
Good oral and written communication skills, including paraphrasing
Good command of English and ability to translate information to/from the local language
Computer literate with the ability to work within multiple databases
Previous exposure to Microsoft Office packages (Outlook, Teams, Word, Excel, PowerPoint)
Understanding the importance of and compliance with procedural documents and regulations
Ability to manage and prioritize tasks and meet strict deadlines with limited supervision
Strong attention to detail
Ability to maintain a positive and professional demeanor in challenging circumstances
Ability to work effectively within a team to achieve a shared goal

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Safety Specialist

Job Description

Safety Specialist

Job Description

Discover Impactful Work

A Day in the Life

Education

Knowledge, Skills, Abilities

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