Associate Director

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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.

Tutti i potenziali candidati sono invitati a leggere con attenzione i seguenti dettagli prima di inviare la propria candidatura.
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).
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.
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 elevate local safety matters appropriately.
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

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