Manager, Patient Support Programs Governance & Quality

The Manager of US Patient Support Programs (PSP) Governance & Quality is responsible for ensuring overall compliance and adherence to defined Governance for US Patient Support Programs. This role covers PSP vendor oversight of end-to-end processes and documentation standards, including Pharmacovigilance reporting, KPI program requirements, 1st line monitoring (1LM), vendor management control, and documentation of any identified deviations from SOPs, and department processes and policies.

Serve as the point of contact for internal and external audits

• Stakeholder coordination: Align audit scope, timelines, and resourcing with Internal Audit, process owners, and leadership; schedule fieldwork and walkthroughs.
• Documentation readiness: Ensure policies, SOPs, process maps, risk/control matrices, and evidence repositories are current and accessible.
• Evidence management: Orchestrate timely, complete, and accurate evidence collection; maintain an audit trail and version control.
• Issue management: Track findings, validate root causes, agree action plans/owners/dates, and monitor remediation through closure.
• Governance and reporting: Provide status updates, metrics, and risk themes to senior leadership and relevant committees; escalate roadblocks.
• Continuous improvement: Translate lessons learned into control enhancements, SOP updates, and training; monitor readiness for future audits.

Manage US PSP Governance: work with Patient Safety, Drug safety, Quality, Legal, Compliance, external vendors, to establish a defined process for screening, evaluating, and monitoring US Patient Support Programs. This includes oversight of activities related to identifying unreported Adverse Events, ensuring appropriate data protection controls, avoiding corporate practice of medicine, and tracking mechanisms to ensure eligibility requirements are met. Ensure appropriate processes are in place and continuously adhered to. Lead the development and ongoing management of US PSP Governance Board requirements, including preparation of program to ensure all PSP-related activities meet governance expectations and are consistently presented for review, decision making, risk mitigation, and continued oversight by the Governance Board.

Identify opportunities for continuous improvement and/or streamlining of process as the business and services evolve to ensure continued “fit for purpose” of governance process.

• Ensure deviations and corrective actions are appropriately documented, communicated, monitored, and acted upon with appropriate cross-functional partners. Escalate issues as appropriate.
• Represent US PSPs on internal vendor audits. Partner with cross-functional teams to ensure any identified audit findings or gaps are appropriately corrected, followed up, and closed within established timelines.
• Ensure secure and appropriate access to all PSP Governance documentation (SOPs, working process documents, deviations, and corrective actions).

Lead the monthly monitoring activities to maintain consistent oversight of key operational activities for Patient Services and ensure compliance.

• Ensure monitoring activities are performed and reported in a timely manner
• Assess current monitoring activities to ensure alignment with organizational objectives
• Identify gaps in monitoring areas and provide remediation plan

• Advanced experience in the pharmaceutical or biotech industry working in Pharmacovigilance, Patient Services, Drug Safety or a related field.
• Relevant Degree qualification: typically, a Bachelors or Master’s in health science with 8+ years of experience
• Pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing both clinical development and post-marketing activities
• Ability to communicate and work closely with legal, compliance, drug safety, quality, and vendor partners in establishing and monitoring governance
• History of high performance in prior roles
• Rare disease/high-value biologics experience is helpful