Associate Director, Pharmacovigilance Lead

4 days ago

Sydney, New South Wales, Australia Eli Lilly Full time
Job Summary

The Associate Director, Pharmacovigilance role is a critical position within Eli Lilly's North Asia-Pacific (NAPAC) region. This individual will provide leadership and management for pharmacovigilance teams across the NAPAC Hub, ensuring quality and compliance in pharmacovigilance operations. The successful candidate will collaborate with internal and external stakeholders, drive continuous improvements in processes, and implement relevant regulations into safety systems.

Key Responsibilities
  • Establish and maintain Lilly's local pharmacovigilance system, ensuring compliance with legal requirements and Good Vigilance Practice (GVP) regulations.
  • Provide strategic direction for pharmacovigilance activities, including adverse event management, expedited and periodic reporting, risk management, and creation and maintenance of the Pharmacovigilance System Master File.
  • Evaluate safety and compliance issues with global management and facilitate execution of corrective and preventive action plans as needed.
  • Act as an interface between Global Patient Safety (GPS) and NAPAC safety personnel, ensuring effective communication and collaboration.
  • Manage regional communication networks, lead regular meetings with NAPAC safety personnel, and serve as a key resource for pharmacovigilance within NAPAC.
  • Provide technical expertise to aligned affiliates and GPS on the interpretation and implementation of relevant pharmacovigilance legislation and regulations.
  • Ensure continuity of adverse event reporting by coordinating back-up personnel during vacations for pharmacovigilance activities.
  • Review metrics to monitor quality and compliance activities and implement corrective and preventative actions.
  • Support review of local business agreements that require safety and regulatory input, ensuring required agreements are in place, up-to-date, and followed as required.
  • Define strategies and lead responses to complex technical issues for specific safety aspects in relation to projects and various activities.
  • Support negotiations with health authorities and review responses to regulatory agency requests, queries, PSURs, and RMPs as needed.
  • Establish and ensure continuous improvement of global, regional, and local pharmacovigilance procedures and quality culture.
  • Represent subject matter expertise for pharmacovigilance at high-level decision-making.
  • Optimize the value of Lilly products through the promotion of patient safety.
  • Establish key relationships within the industry network to gather relevant information that might influence safety activities and leverage gathered knowledge to improve patient safety.
People Management
  • Recruit, train, and develop skilled individuals motivated to work with high-quality standards and achieve department and company objectives.
  • Ensure completion of employee performance objectives and development plans through annual employee performance evaluations.
  • Implement performance management, career management, and succession planning to maximize career potential, retain talented people for the long term, and maximize value to the corporation.
Standards and Inspection Readiness
  • Coordinate and strive for inspection and audit readiness, participating in affiliate inspections, audits, and assessments.
  • Ensure relevant safety standard operating procedures (SOPs) and Business Continuity Plans (BCPs) are well understood across aligned affiliates, leading, testing, and providing clarification on local implementation.
  • Support the development of global SOPs to ensure alignment with relevant laws and regulations.
  • Responsible for ensuring compliance with MoH/regulatory authority requirements and GPS policies, procedures, and processes.
Personal Data Protection
  • Act in accordance with respecting privacy and other related procedures.

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