Sr. Scientist Pharmacovigilance Operations Oversight and Strategy
Core
Ensures patient safety by overseeing global pharmacovigilance case processing, vendor quality/compliance, and safety data reporting for Haleon's consumer health products.
Role type
Senior Scientist, Pharmacovigilance Operations Oversight & Strategy
Builds
Global safety database, vendor oversight model, and regulatory compliance frameworks for Single Case Processing (SCP).
Domain
Consumer Health / Pharmacovigilance / Regulatory Compliance
Deliverable
Production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
Vendor oversight, Pharmacovigilance operations, Regulatory compliance (CIOMS, ICH, GVP, FDA, EMA, MHRA, PMDA), ICSR management, Safety database management, CAPA facilitation, Health Authority interaction, Process improvement, Strategic planning
Preferred skills
Deputizing leadership, PV intelligence, Safety automation, Business insights and analytics
Technologies
Global safety database, ICSRs, Safety Management Plans, Quality Management Plans, Communication Plans
Responsibilities
Lead development and maintenance of the global safety database; Support vendor oversight to ensure quality and compliance in case processing; Provide expert strategy and oversight on ICSR processes; Support Health Authority interactions and inspections; Facilitate root cause analysis and CAPA creation for process issues; Drive implementation of performance and process improvement initiatives.
Seniority
Senior, hands-on IC with strategic oversight