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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in managing Global Patient Safety technology platforms, including Oracle Argus Safety, while ensuring compliance with GxP validation and global safety reporting standards. Proven ability to lead multi-disciplinary teams, manage budgets, and drive strategic initiatives in the biotech, pharma, or life sciences sectors.
Highest-signal resume keywords
Global Patient Safety ManagementOracle Argus Safety ExpertiseBudget ManagementGxP Validation PracticesExecutive Communication
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Patient Safety SystemsSignal ManagementRisk Management PlatformsRegulatory RequirementsTechnology Capability IdentificationSolution Delivery Life Cycle ManagementIncident ManagementRelease GovernanceData IntegrityAudit-Readiness
Soft Skills
Stakeholder ManagementNegotiation SkillsTeam DevelopmentLeadershipCoaching
Tools & Technologies
ArgusPIVITSignal ManagementARMM/ARMMSRP
Certifications & Qualifications
PMPITILSAFe Agile
Industry Keywords
BiotechPharmaLife SciencesE2BICSRFDAEMA
Tech Stack
Tools & technologiesOraclePMP
About the role
Key responsibilities & impact- Serve as the key interface between Global Patient Safety business leadership and Digital & Technology
- Orchestrate Digital & Technology capabilities to deliver Global Patient Safety objectives across Argus, PIVIT, Signal Management, aRMM/ARMM, and SRP
- Own and prioritize the multi-year platform strategy and roadmap
- Lead a team of Directors delivering governance and regulatory-compliant operations across the safety technology portfolio
- Define organizational structure, role allocation, and resourcing for the GPS Business Solution function
- Establish governance frameworks, standards, and validation practices
- Own budget, forecast, software licensing, services agreements, and vendor contract accountability
- Oversee planning, prioritization, execution, product backlog, incident management, and release governance
- Coach and develop Directors and Managers
- Manage steering committee meetings, working groups, and issue/release management
- Ensure platforms meet GxP validation, data integrity, audit-readiness, and global safety reporting standards
- Oversee case processing, signal detection, and risk management workflows
- Partner with Enterprise IT, Enterprise Architecture, Information Security, Regulatory Affairs, Quality, and platform vendors
- Represent GPS technology priorities in enterprise architecture and governance forums
- Engage senior GPS and IT leadership on complex or ambiguous issues
- Monitor drug safety technology and regulatory reporting trends
- Prepare and deliver executive-level materials on platform portfolio health and roadmap
Requirements
What you’ll need- Bachelor’s degree in Computer Science, Information Systems, Business Administration, or a related field
- 15+ years of progressive industry/relevant professional experience
- Significant experience managing enterprise-scale Global Patient Safety, drug safety, or regulatory technology platforms
- Experience in the biotech, pharma, or life sciences industry strongly preferred
- Proven experience leading a multi-disciplinary team of Directors and Managers
- Budget and vendor contract accountability for a major function
- Deep expertise in patient safety and drug safety systems, including Oracle Argus Safety, signal management, and risk management platforms
- Experience with global safety reporting standards and regulatory requirements, including E2B, ICSR, FDA, and EMA
- Strong knowledge of GxP validation practices and solution delivery life cycle management
- Experience managing technology capability identification, selection, and implementation across multiple simultaneous safety platform initiatives
- Proven track record of budget and vendor management
- Strong stakeholder management and negotiation skills
- Demonstrated ability to grow, motivate, and develop teams
- Ability to define organizational structure and set long-term goals and objectives
- Exceptional executive communication skills
- PMP or equivalent project/program management certification preferred
- ITIL or SAFe Agile certification preferred
Benefits
Comp & perks- Relocation benefits if eligible
- Annual bonuses or other incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Medical, dental, vision, life, and disability insurance benefits
- Paid time off
- Family support benefits
- Reasonable accommodation during the recruitment process for applicants with known disabilities or chronic illnesses
