FSP Pharmacovigilance Coordinator – Night Shift

Thermo Fisher Scientific

. Coordinate timely review of protocol inquiries, serious and non-serious adverse events, diagnostics and Data Safety Monitoring Board data .

Posted 9/22/2026full-timeRemote • PhilippinesJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates strong project coordination and data management capabilities, with a focus on compliance with FDA Regulations and ICH Good Clinical Practices. Proficient in effective communication and relationship-building with clients and project teams while maintaining attention to detail and accuracy.

Highest-signal resume keywords

Project CoordinationData ManagementFDA Regulations KnowledgeEffective CommunicationProblem-Solving Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Data EntryReport GenerationContract ReviewAdverse Event TrackingMeeting FacilitationProject-Specific TrainingBudget ManagementConfidentiality Disclosure AgreementsAdjudication Dossier CompilationData Analysis

Soft Skills

Relationship BuildingAttention to DetailFlexibilityInterpersonal SkillsTime Management

Tools & Technologies

MS OfficeTracking SystemsBudget Management SystemsClient Portals

Certifications & Qualifications

High School DiplomaRelevant Vocational QualificationTechnical Certificate (if applicable)

Industry Keywords

PharmacovigilanceGood Clinical PracticesData Safety Monitoring BoardClinical Project ImplementationSOPs

About the role

Key responsibilities & impact

Coordinate timely review of protocol inquiries, serious and non-serious adverse events, diagnostics and Data Safety Monitoring Board data
Track required data and generate reports for clients, project teams and external vendors
Represent the DSMB/EAC Coordination Team at global and domestic committee meetings via teleconference and face-to-face formats
Coordinate meeting logistics and assist with facilitation alongside clients, board members, third-party vendors and project teams
Prepare Confidentiality Disclosure Agreements, Letters of Intent and Member Agreements
Review contractual documents for accuracy and coordinate internal and external approvals
Compile adjudication dossiers and create/submit follow-up to investigative sites
Coordinate and facilitate project meetings; draft minutes and distribute blinded/unblinded materials through client portals
Manage project-specific training and program file setup, maintenance and archival to keep pharmacovigilance programs audit-ready
Identify and redact subject identifiers, retrain sites and escalate recurring issues to Data Privacy
Perform data entry into databases, tracking systems and budget management systems
Reconcile systems to identify issues that may negatively affect project timelines
Oversee expenses and manage translations within budget parameters
Answer incoming hotline calls and coordinate department functions
Support activities performed by the local office that cannot be performed elsewhere
Provide training to junior staff

Requirements

What you’ll need

High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
Technical positions may require a certificate
Previous experience providing the knowledge, skills, and abilities to perform the job (comparable to at least 2 years)
Strong problem-solving skills
Ability to work independently with minimal supervision
Ability to build strong relationships
Ability to analyze project-specific data/systems for accuracy and efficiency
Effective liaison and respectful, diplomatic communication with clients, management, project team members and internal staff
Effective oral, written communication and interpersonal skills
Excellent computer skills, including MS Office (Word, Excel, PowerPoint, Access)
Ability to prioritize and perform multiple tasks simultaneously under strict deadlines
Strong attention to detail and accuracy
Flexibility to reprioritize workload according to changing project timelines
Working knowledge of applicable FDA Regulations, ICH Good Clinical Practices, organizational/client SOPs and WPDs for non-clinical and clinical project implementation, execution and closeout
Ability to work night shift / long varied hours when required
Potential drives to site locations and rare travel may be required

Benefits

Comp & perks

Fully remote work arrangement
Full-time employment
Standard Monday–Friday work schedule
Training and development opportunities, including training to junior staff