Associate Director / Director - Regional Pharmacovigilance Leader (Asia PAC)
lilly · AU: Australia, Australia
At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.
PURPOSE
The purpose of the Associate Director / Director, Regional Pharmacovigilance role is to provide operational and people leadership across pharmacovigilance activities for the aligned regional hub, translating global pharmacovigilance strategy into consistent execution across the region, and also working with other regional PV leaders to ensure consistency and cross-application of learnings when appropriate. This role is accountable for ensuring consistency, quality, compliance, and continuous improvement of pharmacovigilance operations across all affiliates within the region, serving as the primary link between regional affiliate safety personnel, Global Patient Safety (GPS), Qualified Persons for Pharmacovigilance (QPPVs), and the Medical Quality Organization (MQO).
The Associate Director / Director leads a team of affiliate-level pharmacovigilance professionals, drives cross-functional integration of pharmacovigilance capabilities, and represents the region in GPS-level governance and strategy. While holding a Local QPPV / responsible person nomination is not a core expectation of this role, where the role holder meets the residency, language and qualification requirements of a market in their hub, they may hold that nomination, subject to a documented assessment that sufficient time is available for both. The accountability described in this job description is for ensuring the nominations are filled, qualified and supported, whether or not the role holder personally holds one.
PRIMARY RESPONSIBILITIES
This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description.
1. Leadership, People Management and Development
- Lead, develop, and motivate regional pharmacovigilance personnel through creation of appropriate objectives and personal development plans.
- Recruit, train, and develop skilled individuals that are motivated to work with a high-quality standard 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.
- Ensure every pharmacovigilance personnel in the region completes onboarding, role-specific training and any locally mandated accreditation before assuming responsibilities, and that the records evidencing this are retained and inspection-ready.
- Work with affiliate leadership and GPS functions to resolve regional operational issues consistently, escalating those that require a global decision or a change to a globally owned process.
- Accountable for ensuring adequate, qualified pharmacovigilance coverage is in place across the region to meet the requirements of every assigned country — including nominated Local QPPV / responsible person and deputy positions where legally mandated — and that changes to those nominations are notified promptly to the relevant health authority.
- Provide regional input into workforce planning and capacity management, ensuring alignment with the single global pharmacovigilance budget and resourcing strategy; the role does not hold a separate regional budget.
- Engage local General Managers and Medical Directors as needed to ensure pharmacovigilance obligations are understood and supported within affiliate business activities and escalate local safety matters appropriately.
2. Regional Pharmacovigilance Strategy and Operations
- Operate and maintain Lilly's regional pharmacovigilance system across all aligned affiliates, including the performance of the quality system and pharmacovigilance activities to promote, maintain and improve compliance with legal requirements and relevant Good Vigilance Practice (GVP) requirements.
- Translate the globally-owned pharmacovigilance strategy into a regional execution plan, working with GPS stakeholders, process owners, QPPVs, and MQO to deliver on GPS and Lilly objectives while maintaining a high degree of compliance.
- Provide operational direction and oversight for the execution of pharmacovigilance activities across the region (such as: adverse event management, expedited and periodic reporting, risk management, and creation and maintenance of the Pharmacovigilance System Master File). This includes obligations for products managed under license-partner or business-alliance agreements.
- Drive regional adoption and consistent local implementation of globally-owned pharmacovigilance processes to maintain the highest regulatory compliance, and surface regional efficiency and improvement opportunities to the global process owners, for both drugs and devices.
- Evaluate safety and compliance issues with global management and facilitate execution of corrective and preventive action plans as needed.
- Act as the primary interface between Global Patient Safety (GPS) and regional affiliate safety personnel.
- Manage the internal regional communication network; lead regular meetings with regional safety personnel and serve as a key resource for pharmacovigilance within the region.
- Establish and maintain relationships with key external stakeholders across the region — national and regional industry associations, professional bodies, pharmacovigilance networks and key opinion leaders — to gather regulatory intelligence, represent Lilly’s position, and contribute to policy development affecting pharmacovigilance obligations in the region.
- Provide technical expertise to aligned affiliates and GPS with respect to the interpretation and implementation of relevant pharmacovigilance legislation/regulation for both drugs and devices across multiple jurisdictions.
- Establish and maintain regional business continuity plans covering all pharmacovigilance activities — not solely AE intake and reporting — including back-up and deputy arrangements for Local QPPV / responsible person roles, and contingency for system, vendor and alliance-partner disruption.
- Ensure relevant stakeholders are made aware of actions initiated for safety reasons for any Lilly product, including both drugs and devices.
- Be accountable for the regional quality oversight chain end to end — monitor quality and compliance metrics and trends across the affiliates in the responsible region, investigate gaps, drive remediation and CAPAs to closure, and report findings and systemic issues to the global GPS process and functional owners.
- Support the review of local business agreements that require safety and regulatory input (such as: business alliances, patient support programs, distribution agreements) and ensure required pharmacovigilance agreements are in place, up to date and followed across the region.
- Oversee the local performance of pharmacovigilance operations vendors and service providers within the region against the centrally-owned vendor governance model; vendor selection and global vendor governance remain centrally owned.
- Define strategies and lead responses to complex technical issues for specific safety aspects