Manager - Patient Safety, Quality and Compliance - Contractor

About the role

The Manager, Safety Quality and Compliance - Contractor will support the development, management, and oversight of processes, systems, and PV inspection preparedness activities related to safety and pharmacovigilance. This role ensures PV compliance with global regulations and contributes to process improvement, inspection readiness, internal/partner audits, and global regulatory inspections. It includes building training models, supporting PV-related agreements, and partnering with PV Operations to provide safety operations support. The role also involves managing and monitoring internal PV activities and external oversight of CROs and vendors providing PV-related services.

Responsibilities

• Support process improvement and gap analysis:
  • Assess impact of existing PV processes when regulatory requirements change and support implementation of changes.
  • Collaborate on preparation and revision of Standard Operating Procedures (SOPs), Work Instructions (WI), and project plans.
  • Coordinate document review with internal and external stakeholders and follow up for timely completion.
• Support authorship and management of PV agreements:
  • Prepare, implement, and oversee compliance for 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 PS&PV department in partnership with the Quality organization.
  • Conduct audit/inspection readiness activities and risk assessments, including development of storyboards and process mapping.
  • Serve as a subject matter expert for internal and partner audits and global regulatory inspections.
  • Prepare/review audit/inspection agendas and plans.
  • Monitor action items for all stakeholders involved in a PV audit/inspection and follow up for timely completion.
• Project management:
  • Support project management and organizational activities on departmental initiatives and projects.
  • Manage and support preparation of meetings, agendas, minutes, and action items to drive results and efficiencies.
• Compliance metrics / Key Performance Indicators (KPI):
  • Collate PV compliance reports of KPIs/metrics using dashboards, Excel, and presentations.
  • Maintain monthly dashboards 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 SMEs and external stakeholders (CROs and 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 multiple stakeholders.
• 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 fields.
• 4+ years in the pharmaceutical industry; 2+ years’ experience in Safety and Pharmacovigilance, specifically within quality and compliance.
• Oncology experience is required.
• Extensive experience in safety quality systems, compliance monitoring, and development/maintenance of standards and training programs.
• Strong knowledge and experience with 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 demonstrated ability to build and lead high-performing teams.
• Strong people and project management experience.
• Strong cross-functional skills and a desire to help the team meet fast-paced growth into global territories; self-motivated.