Manager - Patient Safety, Quality and Compliance - Contractor

About the role

This role supports the development, management, and oversight of processes, systems, and pharmacovigilance (PV) inspection preparedness activities to ensure compliance with global regulations. The Manager, Safety Quality and Compliance will contribute to process improvement, inspection readiness, internal and partner audits, and global regulatory inspections. The position also involves partnering with PV Operations to provide safety operations support, manage internal PV activities, and oversee external CROs and vendors providing PV-related services to Arcus.

Responsibilities

• Process Improvement and Gap Analysis
  • Support impact assessment of existing PV processes when regulatory requirements change and implement updates as needed.
  • Collaborate on preparing and revising Standard Operating Procedures (SOPs), Work Instructions (WI), and project plans to support process development.
  • Coordinate document reviews with internal and external stakeholders and follow up for timely completion.
• Authorship and Management of PV Agreements
  • Support the preparation, implementation, and compliance oversight of safety data exchange agreements (SDEA)/PV agreements (PVA), including contracts with safety reporting.
• Vendor Oversight
  • Partner with PV Operations to provide vendor management and oversight activities to ensure inspection preparedness.
• Audit and Inspection
  • Lead or co-lead PV audits and inspections for the Patient Safety & Pharmacovigilance (PS&PV) department in partnership with the Quality organization.
  • Conduct audit/inspection readiness activities and risk assessments, including developing storyboards and process mapping.
  • Serve as a subject matter expert for internal and partner audits and global regulatory inspections.
  • Prepare and review audit/inspection agendas and plans.
  • Monitor and follow up on action items for all stakeholders involved in PV audits/inspections.
• Project Management
  • Support project management and organizational activities for departmental initiatives and projects.
  • Manage and support the preparation of meetings, agendas, minutes, and action items to drive results and efficiencies.
• Compliance Metrics and Key Performance Indicators (KPIs)
  • Collate PV compliance reports, KPIs, and metrics using dashboards, Excel, and presentation tools.
  • Maintain a monthly dashboard for case volume, submissions volume, and submissions compliance data.
  • Review metrics reports from multiple CROs and the safety vendor, identify discrepancies, and resolve issues with stakeholders.
  • Ensure timely receipt of reports and follow up as needed.
  • Maintain a list of discrepancies and issues with incoming metrics reports.
  • Review incoming partner late cases, request late reasons/CAPA, and escalate trends if noted.
• Safety Deviation and CAPA
  • Partner with internal cross-functional subject matter experts and external stakeholders (e.g., CROs, vendors) to manage quality events, deviations, and CAPA activities related to late safety reporting, process deviations, and non-compliance issues.
  • Initiate, investigate, and complete internal deviations in Veeva, including collaboration with stakeholders and conflict resolution.
• Safety Training
  • Provide support for tracking and oversight of training assignments, compliance dashboard/status reports, and review of training curriculum as needed.

Requirements

• Bachelor’s degree in nursing, pharmacy, or other healthcare-related field.
• 4+ years in the pharmaceutical industry; 2+ years of experience in Safety and Pharmacovigilance, specifically within quality and compliance.
• Oncology experience is required.
• Extensive experience in safety quality systems, compliance monitoring, and the development and maintenance of standards and training programs.
• Strong knowledge of drug safety database systems, document management systems, QC tools, and MedDRA.
• Expert knowledge of FDA, EMA, Asia-PAC, and ICH regulations and guidelines.
• Demonstrated strategic problem-solving and critical thinking skills.
• Excellent interpersonal, communication, analytical, and organizational skills.
• Ability to work effectively in a dynamic, complex, and fast-paced team environment.
• Track record of strong personal performance combined with the ability to build and lead high-performing teams.
• Strong people and project management experience.
• Strong cross-functional skills and a desire to support team growth in global territories; self-motivated.