Leads the PV Systems Technology team providing L3 product ownership for Argus, Veeva Safety, and other core PV systems and tools; defines the service model, SLAs/KPIs, and 24x7 incident/problem/change management.
Oversees environment strategy (DEV/VAL/PROD), configuration management, master data, role‑based access, dictionaries (MedDRA/WHO‑DD), E2B(R3) gateway, integrations (EDC/CTMS/eTMF/CRM), and reporting/analytics.
Plans and executes upgrades/patching and vendor release intake; performs impact/risk analysis, CSV documentation, regression testing, and cutover/rollback under 21 CFR Part 11, EU Annex 11, and GAMP 5.
Manages vendors for hosting/SaaS/managed services; drives SOWs, performance reviews, roadmap alignment, escalation, and audit/assessment readiness.
Partners with QA/Compliance, Data Privacy, and InfoSec to embed risk‑based quality, data integrity, and security by design; ensures CAPA effectiveness and inspection readiness.
Optimizes cost and performance: license management, capacity planning, archiving/retention, monitoring/observability, DR/BCP, and service reliability engineering practices.
Serves as PV systems SME in RFIs/RFPs and bid defenses; aligns platform capabilities to client requirements, supports due diligence, and enables transitions.
Coaches product owners/SMEs; builds a knowledge base, release notes, and training for SPV users; advances automation (workflow rules, quality checks, NLP/RPA for intake) where appropriate.

10–15+ years in PV technology/operations within CRO/biopharma/SaaS/SI;
5+ years leading PV platform teams and complex releases.
Demonstrated experience implementing/administering/upgrading Oracle Argus and/or Veeva Safety and other core PV systems and tools at scale, including validated cloud/SaaS deployments.
Degree in life sciences, pharmacy, engineering, or related field; advanced degree preferred.
Certifications such as ITIL, PMP, or Agile are advantageous.
Strong communication suited to audits, clients, and executive stakeholders; effective representation in governance forums.

We are passionate about developing our people, through career development and progression;
supportive and engaged line management;
technical and therapeutic area training;
peer recognition and total rewards program.
We are committed to building an inclusive culture – where you can authentically be yourself.

Director, Safety & PV – Core Systems Support

Key skills