PV Operations - Head

• Lead and manage end-to-end pharmacovigilance operations across global markets.
• Oversee ICSR intake, triage, processing, medical review coordination, quality control, and regulatory submissions.
• Ensure compliance with expedited and periodic safety reporting requirements.
• Manage daily operational deliverables, resource allocation, workload distribution, and capacity planning.
• Establish operational governance, performance metrics, and productivity benchmarks.
• Drive operational excellence and continuous improvement initiatives.

• Ensure compliance with global pharmacovigilance regulations and guidelines, including:
• ICH guidelines (E2A, E2B, E2D and relevant updates).
• EU GVP modules.
• US FDA pharmacovigilance regulations.
• Applicable local regulatory requirements.
• Oversee implementation and maintenance of PV SOPs, work instructions, and processes.
• Ensure adherence to regulatory reporting timelines and contractual obligations.
• Lead PV compliance monitoring and risk mitigation initiatives.
• Support regulatory inspections, internal audits, and external audits.
• Drive deviation management, root cause analysis, CAPA, and effectiveness checks.

• Provide strategic oversight of global ICSR processing activities.
• Ensure appropriate case triage, prioritization, processing, medical review coordination, and submission.
• Monitor case quality, accuracy, and compliance with reporting timelines.
• Oversee serious, non-serious, solicited, spontaneous, literature, and clinical trial safety cases as applicable.
• Ensure appropriate follow-up strategies and case reconciliation.
• Monitor case backlog and implement corrective measures.

• Manage CROs, third-party vendors, and safety service providers.
• Establish and monitor Service Level Agreements (SLAs), Key Performance Indicators (KPIs), and quality expectations.
• Conduct periodic vendor governance and performance review meetings.
• Oversee safety data exchange agreements and reconciliation processes.
• Identify vendor-related compliance risks and drive mitigation plans.
• Manage escalations and ensure timely resolution of operational issues.

• Oversee PV safety database operations and system-related activities.
• Ensure appropriate utilization and maintenance of safety systems such as:
• Oracle Argus Safety.
• ARISg.
• Veeva Vault Safety.
• Other relevant pharmacovigilance platforms.
• Support system validation, user acceptance testing (UAT), upgrades, and implementation projects.
• Drive automation, digital transformation, and process optimization.
• Ensure data integrity, system compliance, and appropriate access controls.

• Partner with Quality Assurance to maintain PV quality management processes.
• Lead preparation for regulatory inspections and PV audits.
• Ensure availability and accuracy of PV documentation and records.
• Monitor quality trends, error rates, deviations, and CAPA effectiveness.
• Drive preventive actions to reduce recurring quality issues.
• Support maintenance of inspection-ready PV processes.

• Lead, mentor, and develop PV operations teams.
• Manage team performance, productivity, training, and competency development.
• Establish individual and team objectives aligned with organizational goals.
• Develop succession planning and resource management strategies.
• Foster a culture of accountability, quality, and continuous improvement.

• Collaborate with Regulatory Affairs, Clinical Operations, Medical Affairs, Quality Assurance, and Medical Safety teams.
• Provide operational inputs for global safety initiatives.
• Participate in governance meetings and strategic business reviews.
• Manage client relationships and senior stakeholder communications.
• Support new product onboarding, transition activities, and PV process integration.

• Global PV operational oversight.
• MedDRA and WHO Drug coding knowledge.
• ICH E2B(R2)/(R3) reporting requirements.
• Global expedited and periodic safety reporting.
• Safety database management and oversight.
• PV quality management and audit readiness.
• Vendor governance and SLA management.
• PV metrics, dashboards, and performance analytics.
• Process transformation and automation.