Senior Drug Safety Specialist – Night Shift

Thermo Fisher Scientific

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

Posted 10/1/2026full-timeRemote • PhilippinesSeniorWebsite

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. Proficient in clinical study administration and maintaining a thorough understanding of therapeutic areas and disease processes.

Highest-signal resume keywords

Pharmacovigilance ActivitiesClinical Study AdministrationRegulatory ComplianceCritical ThinkingTeam Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Safety Information AssessmentPathophysiology UnderstandingAdverse-Event ProcessingBudget ManagementData AnalysisQuality ReviewClinical Trials CoordinationMetrics ReviewDatabase ManagementDocument Preparation

Soft Skills

Problem-SolvingCommunication SkillsAttention to DetailTime ManagementProfessional Demeanor

Tools & Technologies

Microsoft OfficeDatabasesClinical Trial Management Systems

Industry Keywords

PharmacovigilanceRegulatory RequirementsTherapeutic AreasAdverse-Event ReportingClinical TrialsEndpoint AssessmentData Safety Monitoring

About the role

Key responsibilities & impact

Perform and potentially oversee day-to-day Pharmacovigilance activities in a highly regulated, deadline-driven environment
Collect, monitor, assess, evaluate, research, and track safety information
Collaborate with project team members, clients, investigators, adverse-event reporters, and third-party vendors
Participate in on-call duties for specific projects to ensure 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 to stay current on regulations, practices, procedures, and proposals
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

Requirements

What you’ll need

Bachelor's degree or equivalent and relevant formal academic/vocational qualification
5+ years of previous experience providing the knowledge, skills, and abilities to perform the job
Equivalent 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 adverse-event processing
Excellent critical thinking and problem-solving skills; ability to evaluate and escalate appropriately
Proficiency in complex clinical study administration, including budgets and forecasting
Excellent oral and written communication, including paraphrasing skills
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
Full-time employment
Standard Monday–Friday schedule
Potential on-call duties for 24-hour case-intake coverage
Occasional domestic and/or international travel
Mentoring and professional development through collaboration and development opportunities