Safety Reporting Specialist

Thermo Fisher Scientific

. Manage and coordinate the production of regulatory and safety reports .

Posted 11/3/2026full-timeRemote • IndiaJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing regulatory and safety reports, ensuring compliance with global safety reporting requirements, including FDA regulations. Proficient in utilizing safety databases and Microsoft Office tools to produce metrics and support process improvement initiatives.

Highest-signal resume keywords

Regulatory Reporting ManagementSafety Database FunctionalityFDA Regulations KnowledgeMedical Terminology ProficiencyProject Coordination

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory ReportingSafety ReportingData ManagementQuality AssuranceProcess ImprovementMetrics ProductionSafety Database UsageProcedural DocumentationCritical ThinkingProblem Solving

Soft Skills

Communication SkillsAttention to DetailTeam CollaborationTraining and SupportInterpersonal Skills

Tools & Technologies

Microsoft WordMicrosoft ExcelSafety Reporting SystemsOffice Software

Industry Keywords

Global Safety ReportingRegulatory ComplianceClinical EnvironmentAudit ParticipationSafety Reporting Guidelines

About the role

Key responsibilities & impact

Manage and coordinate the production of regulatory and safety reports
Receive, prepare and submit safety reports to applicable parties
Escalate issues to the lead and/or line manager
Ensure reports comply with regulatory timelines and country legislation
Produce metrics and alert managers to quality or timeline issues
Participate in project teams and lead small- to moderate-scope projects when needed
Provide training and support to team members
Perform administrative tasks, including filing and maintaining safety reporting systems and information
Liaise with departments on safety reporting tasks and client account setup
Participate in audits and perform testing activities as required
Share ideas and suggestions with team members
Participate in process improvement initiatives

Requirements

What you’ll need

Bachelor's degree or equivalent and relevant formal academic / vocational qualification
2+ years of previous experience comparable to the role
Equivalency may consist of a combination of appropriate education, training and/or directly related experience
Strong knowledge of medical terminology
Good written and verbal communication skills
Good Microsoft Word and Excel skills
Solid understanding of safety database functionality
Solid knowledge of procedural documents
Working knowledge of global safety reporting requirements, including FDA regulations and guidelines
Ability to manage multiple tasks while delivering high-quality results
Strong attention to detail and accuracy
Ability to handle sensitive information and data effectively
Ability to interact effectively with all organizational levels
Strong critical-thinking and problem-solving skills
Ability to work in an office, laboratory and/or clinical environment
Ability to work upright and/or stationary for 6–8 hours per day
Ability to perform repetitive hand movements and frequent mobility
Ability to lift and carry 15–20 lbs
Ability to access and use in-house and off-the-shelf computer software
Regular and consistent attendance

Benefits

Comp & perks

Fully remote work arrangement
Standard Monday–Friday work schedule
Collaboration and professional development opportunities
Training and support for team members
Participation in project teams and process improvement initiatives