Description

Summary

The Manager, Safety Quality and Compliance - Contractor will be responsible for supporting the development, management and oversight of processes, systems and PV inspection preparedness activities pertaining to safety and pharmacovigilance to ensure PV compliance with global regulations. This role will be key in contributing to process improvement, inspection readiness, internal/partner audits, and global regulatory inspections to drive compliance, building training models, supporting PV related agreements. This role also includes partnering with PV Operations to provide safety operations support as needed, manage and monitor internal PV activities and external oversight of CROs and vendors providing PV related services to Arcus.

The responsibilities under this role will provide continuous support to achieving corporate and departmental goals to ensure the company’s success in continued growth and expansion.

Responsibilities

Where applicable work independently and collaboratively with the team and directly with the Sr. Director of Patient Safety & Pharmacovigilance - Operations, Quality & Compliance to perform the following:

Core Tasks Support:

Process Improvement and Gap Analysis  

• Support impact assessment of existing PV processes when there are changes to regulatory requirements and support implementation of changes as applicable.
• Collaborate on the preparation and revision of Standard Operating Procedures (SOPs), Work Instructions (WI) and project plan to support process development and improvement.
• Coordinate document review with applicable internal and external stakeholders and follow up as needed for timely completion 

Support Authorship and Management of PV Agreements  

• Support the preparation (authoring), implementation and compliance oversight 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:

• Demonstrate experience of leading/co-leading PV audits and inspections for the PS&PV department and in partnership with Quality organization. 
• Conduct audit/inspection readiness activity and risk assessment, including development of storyboards, process mapping
• Work closely with the department leads to serving as a subject matter expert for internal and partner audits and global regulatory inspections  
• Prepare/review audit/inspection agenda and plan 
• Own the process of monitoring 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, agenda, minutes, action items to drive results and efficiencies

Other Supporting Tasks:

Compliance Metrics / Key Performance Indicators (KPI)

• Collating PV compliance reports of KPIs/metrics using dashboards, excel, presentation, etc.
  • Maintain monthly dashboard – case volume, submissions volume and submissions compliance data populated for pivot and presentation formats. 
  • Review metrics reports from multiple CROs and the safety vendor. Identify discrepancies and work with responsible stakeholders to resolve the issues.  
  • Ensure timely receipt of reports and follow up as needed. 
  • Maintain list of all the discrepancies and issues with the incoming metrics reports. 
  • Review incoming partner late cases and request late reason/CAPA. Escalate any trends if noted. 

Safety Deviation and CAPA

• Partner with internal cross-functional SMEs and external stakeholders like 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. This includes collaboration with multiple stakeholders and receiving input, conflict resolution.

Safety Training:

• As needed, provide support to tracking and oversight of training assignments, compliance dashboard/status reports, review of training curriculum.

Qualifications
 

• Bachelor’s degree in nursing, pharmacy, or other health care related fields.
• 4+ years in the pharmaceutical industry setting; 2+ years’ experience working 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 and experience with available drug safety database systems, document management systems, QC tools, as well as 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.
• Demonstrated 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 and be self-motivated

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