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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing patient safety projects, ensuring regulatory compliance, and delivering high-quality outcomes while maintaining strong client relationships. Proficient in pharmacovigilance systems, budget planning, and project management within the healthcare sector.
Highest-signal resume keywords
Project ManagementPharmacovigilance SystemsRegulatory ComplianceBudget PlanningClinical Research
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Drug DevelopmentClinical AdjudicationData MonitoringIDRA WorkflowsContract ManagementRevenue RecognitionFinancial ManagementResource EstimationScope Change ManagementSafety Database Management
Soft Skills
LeadershipTeam-BuildingProblem-SolvingCollaborationCommunication
Tools & Technologies
Adjudication Technology Platforms
Industry Keywords
Patient SafetyICHFDAEMAGCPHealthcarePharmacovigilanceClinical OperationsData ManagementStakeholder Management
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Manage comprehensive patient safety projects with accountability for delivery, quality, and financial performance
- Provide leadership and oversight across project teams
- Serve as primary liaison between internal departments and clients
- Ensure regulatory compliance and operational excellence
- Build and maintain collaborative client relationships
- Develop proposals for patient safety services
- Assess scope requirements and provide resource estimations
- Represent Parexel at client meetings, bid defenses, and governance forums
- Act as single point of contact for assigned partnerships
- Develop and maintain project plans with milestones and timelines
- Monitor task progression and implement corrective actions
- Manage budgets and compare actual versus planned costs
- Oversee scope change management and revenue recognition
- Provide status updates to clients and internal stakeholders
- Coordinate with Project Analysts on financial matters
- Coordinate with Business Operations, Clinical Operations, and Data Management teams
- Manage relationships with external stakeholders and vendors
- Provide guidance on ICH, FDA, EMA, and GCP regulatory compliance
- Partner with Subject Matter Experts to improve processes and methodologies
- Provide functional oversight and potentially supervise direct reports
- Ensure deliverables meet client expectations and regulatory standards
- Maintain knowledge of industry regulations and patient safety trends
- Apply expertise in pharmacovigilance systems and safety database management
- Support Clinical Adjudication Committees and Data Monitoring Committees
Requirements
What you’ll need- Very strong experience in drug development, healthcare, or pharmacovigilance
- Proven project management experience with demonstrated team leadership
- Specialized experience in clinical adjudication and data monitoring committee processes
- Proficiency with IDRA workflows, committee governance, and adjudication technology platforms
- Strong knowledge of pharmacovigilance systems and regulatory requirements
- Expertise in contract management, budget planning, and revenue recognition
- Fluent written and verbal English communication
- Leadership and team-building abilities
- Budget planning and financial management
- Advanced prioritization and multitasking
- Problem-solving with ability to manage multiple complex projects
- Collaborative approach to matrix environments
- Understanding of clinical research and drug development processes
- Strong written and verbal communication
- Degree in Pharmacy, Nursing, Life Science, or related health field (or equivalent pharmacovigilance experience)
Benefits
Comp & perks- Remote work based in Ireland