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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Pharmacovigilance quality standards, regulatory compliance, and training program development. Proficient in document management systems and effective communication within cross-functional teams.
Highest-signal resume keywords
Pharmacovigilance Quality StandardsGlobal Pharmacovigilance RegulationsTraining Program DevelopmentDocument Management SystemsMicrosoft Office Suite
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Pharmacovigilance Quality StandardsGlobal Pharmacovigilance RegulationsTraining Program DevelopmentDocument Management SystemsLearning Management SystemsProcedural Document DevelopmentVeeva eLMSVeeva eDMSCFR/GVP KnowledgeICH Guidelines
Soft Skills
Strong Verbal CommunicationStrong Written CommunicationOrganizational SkillsTime ManagementProblem-Solving SkillsTeam Collaboration
Tools & Technologies
Microsoft WordMicrosoft ExcelMicrosoft OutlookMicrosoft PowerPointVeeva eLMSVeeva eDMS
Industry Keywords
PharmacovigilanceRegulatory ComplianceQuality StandardsTraining RecordsAudit Processes
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Ensure compliance with internal procedures, regulatory requirements, and partner agreements to ensure inspection readiness
- Coordinate development, review, and maintenance of Pharmacovigilance quality standards documents
- Support management of documents through the approval lifecycle within document management systems
- Train Pharmacovigilance and external service provider/vendor staff as requested
- Assist with support and identification of cross functional specific SOPs requiring GPRM training
- Maintain Pharmacovigilance training records to ensure documentation is accurate, up to date, and inspection ready
- Support development and maintenance of Pharmacovigilance training programs and initiatives
- Provide technical expertise on Pharmacovigilance quality standards and training processes
- Identify quality issues, propose solutions, and escalate as appropriate
- Support Pharmacovigilance audit processes and inspections as needed
- Review and provide feedback on Pharmacovigilance documents and templates as requested
- Assist with updates to the Pharmacovigilance System Master File as applicable
- Collaborate with intradepartmental teams, business partners, and external service providers
Requirements
What you’ll need- Proficiency in written and verbal English to effectively communicate in the workplace
- Strong verbal and written communication skills
- Strong organizational, time management, and problem-solving skills
- Demonstrated ability to work effectively within a team environment
- Proficiency in Microsoft Word, Excel, Outlook, and PowerPoint
- Knowledge of global Pharmacovigilance regulations (CFR/GVP), ICH Guidelines, and GCP
- Experience preparing and delivering training to a variety of audiences
- Experience working with learning management systems; proficiency with Veeva eLMS preferred
- Experience developing procedural documents and working with document management systems; proficiency with Veeva eDMS preferred
- Bachelor’s degree in a science or healthcare-related discipline, or equivalent experience
- Employment with ICON is contingent upon having the legal right to work in the country where the role is based
Benefits
Comp & perks- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
