Head of Pharmacovigilance Operations and Compliance

Deerfield, IllinoisCompany: Planet Pharma GroupContact: ApplicationsEmail: View email address on click.appcast.io PV OperationsThe 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 ManagementCoordinate 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 OversightMonitor 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.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.Inspection and Audit ReadinessMaintain 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 requested documentation, inspection narratives, evidence packages, subject matter experts, and operational demonstrations.Participate in inspections and audits as a PV operations, compliance, and vendor oversight subject matter expert.Coordinate responses, commitments, corrective actions, and evidence of remediation arising from inspections and audits.PV Documentation, Training and Change ImplementationCoordinate implementation and maintenance of PV SOPs, work instructions, guidance documents, templates, and governance tools within the role’s assigned scope.Ensure that applicable personnel, vendors, partners, and other external parties receive required PV or safety information and training.Monitor completion and documentation of required PV training and follow up on identified gaps.Assess operational impacts of new or revised regulations, products, studies, programs, agreements, vendors, or business arrangements.Coordinate implementation of approved PV process, system, agreement, or organizational changes.Ensure that PV records and governance documents are maintained in designated systems and repositories in accordance with applicable requirements.Safety Governance and Cross-Functional CoordinationSupport signal management, safety surveillance, aggregate reporting, and safety governance processes by ensuring that required operational inputs, data, documentation, and vendor deliverables are available.Coordinate escalation of emerging safety issues, significant compliance risks, and other matters requiring medical, regulatory, quality, or executive review.Facilitate cross-functional communication and action tracking related to safety decisions, risk minimization activities, and PV commitments.Ensure that operational actions arising from safety governance decisions are assigned, monitored, and documented.Escalate matters requiring strategic direction, medical judgment, benefit-risk determination, or final PV accountability to the Vice President, Pharmacovigilance.Leadership and CollaborationProvide functional or line management to assigned PV personnel, as applicable.Establish clear responsibilities, priorities, performance expectations, and escalation pathways for assigned staff and vendors.Support hiring, onboarding, development, coaching, and succession planning within the PV function.Foster a culture of patient safety, compliance, continuous improvement, and inspection readiness.Demonstrated knowledge of ICSR management, regulatory reporting, literature surveillance, aggregate reporting, reconciliations, safety data exchange, and safety database operations.Experience establishing and monitoring performance metrics, compliance indicators, governance actions, and escalation pathways.Working knowledge of deviations, investigations, CAPAs, change controls, audits, inspections, and inspection-readiness practices.Strong documentation, organization, issue-management, and evidence-retrieval skills.Ability to distinguish operational oversight responsibilities from medical decision-making, independent Quality responsibilities, and final PV accountability.Ability to manage multiple priorities independently in a regulated, fast-paced setting.Advanced clinical, scientific, regulatory, quality, or business degree is preferred but not required.ExperienceMinimum of 8 years of relevant pharmaceutical, biotechnology, healthcare, or pharmacovigilance experience.At least 5 years of progressively responsible experience in pharmacovigilance operations, compliance, quality, or vendor oversight.Demonstrated experience overseeing outsourced or delegated pharmacovigilance activities.Experience supporting regulatory inspections, audits, vendor governance, investigations, and corrective actions.Previous people-management, functional-leadership, or significant vendor-governance experience preferred.