Senior Safety Specialist

Thermo Fisher Scientific

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

Posted 9/18/2026full-timeRemote • MexicoSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Pharmacovigilance activities, including case review, regulatory compliance, and clinical study administration. Proficient in mentoring staff and collaborating with diverse project teams while maintaining a strong understanding of therapeutic areas and disease processes.

Highest-signal resume keywords

Pharmacovigilance ActivitiesClinical Study AdministrationRegulatory ComplianceCritical ThinkingBudget Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

PharmacovigilanceCase ReviewClinical TrialsData Safety MonitoringPathophysiologyTherapeutic AreasBudget ActivitiesForecastingRegulatory RequirementsComputer Literacy

Soft Skills

Critical ThinkingProblem-SolvingCommunicationAttention to DetailTeam Collaboration

Tools & Technologies

Microsoft OfficeDatabases

Industry Keywords

PharmacovigilanceAdverse EventsRegulatory ComplianceClinical TrialsInvestigative Sites

About the role

Key responsibilities & impact

Perform and potentially oversee day-to-day Pharmacovigilance activities in a highly regulated environment
Participate in on-call duties for specific projects to provide 24-hour coverage for case intake 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/pharmacovigilance publications and information sources
Maintain medical understanding of applicable therapeutic areas and disease states
Review cases for quality, consistency, and accuracy, including peer reports
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
Collaborate with project teams, clients, investigators, adverse-event reporters, and third-party vendors

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
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 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
Occasional domestic and/or international travel required

Benefits

Comp & perks

Collaboration and development opportunities
Global team environment
Scientific excellence-focused workplace