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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates advanced expertise in pharmacovigilance safety technology systems, regulatory compliance, and change management, with strong capabilities in technical writing and communication. Proven ability to lead teams, mentor members, and deliver technology solutions aligned with safety operations.
Highest-signal resume keywords
Safety Database ManagementPharmacovigilance Technology SystemsRegulatory Compliance (21 CFR Part 11, EMA Annex 11, GAMP)Technical Writing and CommunicationChange Management and System Validation
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Safety Supportive Applications (Argus, Vault Safety, EDC, Safety ERP)SQL ScriptingSystem AdministrationApplication SupportSystem Validation Design and Execution
Soft Skills
Interpersonal CommunicationAnalytical Problem-SolvingLeadership and Mentoring
Tools & Technologies
Service Desk ToolsSafety Technologies Integration
Industry Keywords
PharmacovigilanceGood Pharmacovigilance Practices (GVP)Good Clinical Practice (GCP)Change ManagementSoftware Development Life Cycle (SDLC)
Tech Stack
Tools & technologiesERPSDLCSQLVault
About the role
Key responsibilities & impact- Lead the setup, configuration, and support of Parexel's safety database and associated systems
- Implement new studies, generate periodic and ad-hoc reports, configure expedited report rules, and provide comprehensive end-user support
- Direct safety database handovers between clients and Parexel at project start and completion
- Design and deliver integrations between Parexel safety technologies and other applications
- Represent Safety Technology Management with IT, Quality Assurance, and external auditors
- Ensure compliance with regulatory requirements, security standards, and quality protocols
- Lead change management aligned with Software Development Life Cycle principles, including impact assessments, testing, system validation, and software updates
- Develop presentations and technical documentation, including standard operating procedures and controlled documents
- Lead technical issue analysis and resolution with IT, vendors, Safety Services staff, and clients
- Train, coach, and provide work direction to team members
- Collaborate with the Global Pharmacovigilance Intelligence Office to maintain regulatory compliance and address evolving requirements
Requirements
What you’ll need- 5+ years of hands-on experience with safety supportive applications (Argus, Vault Safety, EDC, Safety ERP) across all functional areas and secondary tools
- 5+ years of experience working closely with safety operations teams to manage issues, gather requirements, and deliver technology solutions
- Advanced knowledge and practical application of computer system regulations and guidance (21 CFR Part 11, EMA Annex 11, GAMP)
- Demonstrated proficiency with standard scripting languages (SQL) and industry-standard Service Desk Tools
- Strong technical writing capability and proven ability to communicate complex concepts clearly to diverse audiences
- Advanced technical expertise in pharmacovigilance safety technology systems, including complex configurations, system administration, and application support
- Exceptional interpersonal, verbal, and written communication skills
- Advanced analytical and problem-solving capabilities
- Strong leadership presence and ability to mentor team members
- Demonstrated experience in system validation, change management, and regulatory compliance
- Knowledge of emerging pharmacovigilance technologies, including AI
- Deep understanding of pharmacovigilance roles, standards, practices, GVP, and GCP requirements
- 1+ years of direct mentorship, training, or peer oversight experience (preferred)
- Demonstrated lead participation in system/process improvement initiatives and 1+ years of system validation design and execution (preferred)
- BA/BSc in Engineering, Computer Science, or related field (preferred); master's degree preferred
Benefits
Comp & perks- Flexibility and space to do your best work
- Continuous learning opportunities
- Career development opportunities across clinical research technology, regulatory compliance, and strategic system implementation