Director PV Operations

Reference: 630772

Posted:

Location:

Deerfield, Illinois Company:
Planet Pharma Group Contact:
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Director PV Operations The Director, Pharmacovigilance Operations is responsible for coordinating PV operations, monitoring PV compliance, and overseeing vendors and external parties performing delegated pharmacovigilance activities. The role ensures that operational processes are implemented consistently, vendor performance and compliance are monitored, and PV documentation and evidence remain inspection ready. The Director partners with internal functions and external service providers to identify operational or compliance risks, coordinate remediation, and escalate significant matters to the Vice President, Pharmacovigilance.

PV Operations Management Coordinate the implementation and ongoing performance of pharmacovigilance operational processes, including adverse event intake, case processing, regulatory reporting, literature surveillance, reconciliations, aggregate reporting support, and safety data exchange.

Ensure operational interfaces among Pharmacovigilance, Medical, Clinical, Regulatory, Quality, Commercial, and other relevant functions are defined and functioning effectively.

Monitor operational activities, deliverables, due dates, and dependencies and escalate material delays, risks, or resource constraints.

Support implementation of product, partner, study, and program-specific PV requirements within the established PV system.

Maintain operational oversight information needed to support PV governance and management review.

PV Compliance and Quality Oversight Monitor PV operations for compliance with applicable regulatory requirements, pharmacovigilance agreements, contracts, company procedures, and documented PV system requirements.

Review PV compliance metrics, quality indicators, deviations, late activities, reconciliation results, and recurring operational issues.

Coordinate timely investigation, documentation, escalation, and remediation of PV compliance issues.

Partner with Quality on deviations, root cause analyses, corrective and preventive actions, audits, and inspection responses.

Identify compliance trends and recommend procedural, training, vendor, or system improvements.

Support periodic evaluation of PV system effectiveness and inspection readiness.

Vendor and External Party Management Serve as the primary PV operational contact for vendors and external parties performing delegated pharmacovigilance activities.

Coordinate onboarding, implementation, governance, routine oversight, performance review, and offboarding of PV vendors, license partners, service providers, and other external parties.

Confirm that delegated PV responsibilities, deliverables, interfaces, escalation pathways, and evidence expectations are clearly documented.

Monitor vendor performance through defined metrics, governance meetings, issue tracking, reconciliations, quality reviews, and documented follow-up.

Identify vendor-related compliance, quality, capacity, or performance risks and ensure appropriate escalation and remediation.

Coordinate PV input into vendor qualification, audits, contracts, statements of work, pharmacovigilance agreements, and change controls.

Maintain or oversee vendor governance records, communication records, contact information, decisions, actions, and supporting evidence.

Inspection and Audit Readiness Maintain preparedness for regulatory inspections, partner audits, vendor audits, due diligence activities, and internal assessments involving the PV system.

Confirm that PV governance documentation, inventories, agreements, training records, oversight records, metrics, and supporting evidence are current, traceable, and retrievable.

Coordinate preparation of…