Pharmacovigilance Project Specialist

Premier Research

. Partner with Drug/Device Safety Officers, Safety Project Managers, and senior management to coordinate and oversee cross-functional study teams and ensure overall PV project delivery .

Posted 10/28/2026full-timeRemote • Bulgaria, Slovakia, Romania, SpainMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Pharmacovigilance and compliance with ICH/GCP regulations, while effectively managing project documentation and communication. Proficient in financial tracking and audit preparation within clinical research environments.

Highest-signal resume keywords

Pharmacovigilance ExperienceICH/GCP ComplianceProject Management KnowledgeMS Office Suite ProficiencyClinical Research Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Project Budget TrackingSAE ReportingSOP DevelopmentTrial Master File ManagementKPI Collation

Soft Skills

Effective CommunicationTeam CoordinationOrganizational Skills

Industry Keywords

Clinical ResearchDrug DevelopmentFDA GuidanceEU DirectivesISO14155 Regulations

About the role

Key responsibilities & impact

Partner with Drug/Device Safety Officers, Safety Project Managers, and senior management to coordinate and oversee cross-functional study teams and ensure overall PV project delivery
Ensure compliance with SOPs and ICH/GCP best practices
Maintain project team contact lists and support effective internal and external communications through agendas, meeting minutes, and action/decision logs
Develop, maintain, and update financial tools for tracking project budgets and out-of-scope services
Generate SAE, SUSAR, and AESI report listings for sponsors and internal teams
Support KPI collation and Governance slide deck development
Ensure assigned projects are audit ready and tasks comply with Safety Management Plans, project plans, and SOPs
Manage Trial Master File document collation and indexing
Create and maintain project SOP indices, study team lists, and email distribution lists
Support kick-off meeting slide deck development
Create and maintain project training matrices and documentation of study-specific training
Support preparation for sponsor and regulatory agency audits and inspections

Requirements

What you’ll need

Bachelor’s degree in Life Sciences, Medicine, Pharmacy, or Nursing preferred
Minimum of 1 year of professional work experience in clinical research, healthcare, business, finance, and/or project management preferred
Experience with Pharmacovigilance preferred
Basic knowledge of ICH/GCP regulations
Working knowledge of FDA guidance documents, EU directives, ISO14155 regulations, drug/device development, and clinical monitoring procedures
Basic knowledge of project management terminology and guidelines
Strong computer skills in MS Office suite required
Fluent in English

Benefits

Comp & perks

Flexible work arrangements and work-life balance
Skills and professional growth opportunities