Senior Safety Specialist

Thermo Fisher Scientific

. Regularly monitor and manage GPS mailboxes .

Posted 9/21/2026full-timeRemote • North Carolina • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates advanced knowledge of pharmacovigilance processes and medical terminology, with a strong ability to manage safety information and generate aggregate safety reports in compliance with global regulations. Proficient in utilizing safety database systems and Microsoft Office to deliver high-quality documentation and support operational decision-making.

Highest-signal resume keywords

Pharmacovigilance ProcessesSafety Database Systems (Argus, ArisG)Aggregate Safety Reports (DSUR, PSUR)Medical TerminologyGlobal Regulations (EU, US, Japan)

ATS Keywords

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Hard Skills

Medical TerminologyPharmacovigilance ProcessesAggregate Safety ReportingSafety Event CollectionSafety Database SystemsMedDRA CodingMicrosoft Office ProficiencyWorkflow ManagementRegulatory ComplianceDocument Quality Assurance

Soft Skills

Effective CommunicationProblem SolvingTask PrioritizationCollaborationAdaptability

Industry Keywords

Global PharmacovigilanceDrug SafetyClinical TrialsPost-Marketing SurveillanceSafety Information Management

About the role

Key responsibilities & impact

Regularly monitor and manage GPS mailboxes
Communicate with safety vendors regarding individual case safety reports and aggregate reports/listings
Manage reviews of ICSRs, listings, tables, and figures for completeness and quality
Manage serious adverse event reconciliation across post-marketing and clinical trial databases and listings
Collaborate with clinical, medical, regulatory, healthcare professional, consumer, and contracted-resource stakeholders to obtain safety information
Participate in meetings and take minutes as required
Support generation of aggregate safety reports
Communicate with business partners and distributors regarding receipt and transmission of safety information under applicable data exchange agreements
Attend GPS operational meetings and contribute as a subject matter expert
Identify issues and improvement areas and escalate appropriately
Contribute to developing new processes and procedures
Support implementation of new processes and systems
Perform activities in compliance with client controlled procedures and applicable global and local regulations
Perform other tasks assigned by the line manager or Head of GPS

Requirements

What you’ll need

Fluent communication in written and spoken English
Advanced knowledge of medical terminology, pharmacovigilance processes, and relevant global regulations, including EU, US, and Japan requirements
Ability to communicate complex issues clearly and effectively
Ability to manage and prioritize tasks to meet deadlines
Ability to solve routine problems with limited supervision and raise issues constructively
Ability to deliver high-quality documents, including work instructions, guidelines, forms, and templates
Ability to manage timelines for deliverables with minimal support
Ability to make basic operational decisions while understanding impact and potential risk
Advanced computer skills, including Microsoft Office proficiency
Proficiency with safety database systems such as Argus or ArisG
Proficiency with MedDRA coding
Bachelor's or Master's degree, or local equivalent, in nursing, healthcare, life science, or a relevant field
3–5 years of relevant experience in global pharmacovigilance/drug safety, including EU and US
Equivalent and adequate combination of education and experience
Solid experience with end-to-end safety event collection and reporting
Experience developing and submitting aggregate safety reports such as DSUR and PSUR
Solid expertise in global EU/US pharmacovigilance requirements and practices
Solid experience with safety database systems, including workflow management
Ability to communicate, receive, and understand information and ideas with diverse groups of people
Ability to work upright and stationary for typical working hours
Ability to use and learn standard office equipment and technology proficiently
Ability to perform successfully under pressure while prioritizing and handling multiple projects or activities

Benefits

Comp & perks

Health and wellbeing support
Healthy and balanced work environment
May require travel