Senior Safety Specialist
Thermo Fisher Scientific
Posted: 10/21/2026
Safety & PV Specialist I
Syneos Health
Posted: 10/15/2026
Danish Online Safety Specialist
Atlean World
Posted: 9/26/2026Safety & PV Specialist I, Data Management
Syneos Health
Posted: 9/17/2026Senior Safety Specialist
Thermo Fisher ScientificCore Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
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
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
- Work independently on daily PV activities and potentially participate in on-call duties to ensure 24-hour case-intake coverage
- 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/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/Data Safety Monitoring Committees
- 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 comparable experience
- Equivalency may consist of a combination of appropriate education, training and/or directly related experience
- Thorough understanding of pathophysiology and disease processes
- Strong knowledge of relevant therapeutic areas for adverse-event processing
- Excellent 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
Benefits
Comp & perks- Global team environment
- Collaboration and development opportunities
- Opportunity to contribute to patient safety and scientific excellence
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Safety Information AssessmentPathophysiology UnderstandingAdverse-Event ProcessingBudget ManagementData AnalysisClinical Trials CoordinationQuality ReviewDatabase ManagementForecastingTherapeutic Area Knowledge
Soft Skills
Problem-SolvingAttention to DetailTeam CollaborationProfessional DemeanorTime Management
Tools & Technologies
Microsoft OfficeDatabasesClinical Trial Management Systems
Industry Keywords
PharmacovigilanceRegulatory RequirementsAdverse-Event ReportingClinical ResearchCompliance Standards