Senior Safety Specialist

Thermo Fisher Scientific

. Perform and potentially oversee day-to-day Pharmacovigilance activities in a highly regulated environment .

Posted 10/21/2026full-timeRemote • SerbiaSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Pharmacovigilance activities, including safety information assessment and regulatory compliance, while effectively collaborating with diverse stakeholders and mentoring team members.

Highest-signal resume keywords

Pharmacovigilance ActivitiesRegulatory ComplianceClinical Study AdministrationCritical ThinkingCommunication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Pathophysiology UnderstandingAdverse Event ProcessingBudget ManagementData AnalysisClinical Trials CoordinationQuality ReviewSafety Information TrackingProgram DevelopmentAudit PreparationDatabase Management

Soft Skills

Problem-SolvingAttention to DetailTeam CollaborationMentoringProfessional Demeanor

Tools & Technologies

Microsoft OfficeDatabasesClinical Trial Management Systems

Industry Keywords

PharmacovigilanceTherapeutic AreasGlobal Regulatory RequirementsComplianceAdverse Event Reporting

About the role

Key responsibilities & impact

Perform and potentially oversee day-to-day Pharmacovigilance activities in a highly regulated environment
Collect, monitor, assess, evaluate, research, and track safety information
Collaborate with project team members, client contacts, investigators, adverse event reporters, and third-party vendors
Participate in on-call duties for specific projects to ensure 24-hour case-intake coverage from investigative sites
Operate in a lead capacity and assist with developing program and departmental procedural documents
Prepare for and attend audits
Mentor less experienced staff
Review regulatory and pharmacovigilance publications and information sources
Maintain medical understanding of applicable therapeutic areas and disease states
Review cases and peer reports for quality, consistency, and accuracy
Coordinate routine project implementation, including Clinical Trials and Endpoint Assessment Committee/Data Safety Monitoring Committee activities
Present at client and investigator meetings
Review metrics and budget considerations

Requirements

What you’ll need

Bachelor's degree or equivalent and relevant formal academic / vocational qualification
5+ years of previous experience providing relevant knowledge, skills, and abilities
Equivalency through a combination of appropriate education, training and/or directly related experience may be considered
Thorough understanding of pathophysiology and disease processes
Strong knowledge of relevant therapeutic areas for processing adverse events
Critical thinking and problem-solving skills, including appropriate evaluation and escalation
Proficiency in complex clinical study administration, budget activities, and forecasting
Excellent oral and written communication skills, including paraphrasing
Good command of English and ability to translate information into the local language where required
Computer literacy and ability to work within multiple databases
Proficiency in Microsoft Office, including Outlook, Word, and Excel
Thorough understanding of global regulatory requirements and compliance with procedural documents and regulations
Ability to manage and prioritize varied 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 attain a shared goal

Benefits

Comp & perks

Fully remote work arrangement
Standard Monday–Friday work schedule
Collaboration and professional development within a global team
Mentoring opportunities
Participation in a global team committed to scientific excellence