Associate Director / Director - Regional Pharmacovigilance Leader (Europe)

Eli Lilly and Company; Sesto Fiorentino; Vor Ort; EUR 140.000 - 200.000; Vollzeit

Zusammenfassung

Eli Lilly and Company is seeking an Associate Director/Director for Regional Pharmacovigilance to lead and optimize PV operations across the regional hub. You will translate global strategies into region-wide execution, manage QPPV networks, and drive compliance and continuous improvement in multiple markets.

The role requires strong leadership, PV expertise, and proven ability to coordinate across affiliate safety personnel, GPS, and MQO, ensuring high standards of safety and regulatory

Qualifikationen

• Bachelor's degree in pharmacy, life science, or related field.
• Minimum 5 years of pharmacovigilance experience.
• Experience leading regional PV teams and cross-market collaboration.

Aufgaben

• Provide regional PV leadership and strategic direction across aligned affiliates.
• Ensure compliance with global GPS and local regulatory requirements; manage QPPV network.
• Oversee regional pharmacovigilance operations, including AE management, reporting, and CAPAs.
• Collaborate with GPS, QA, regulatory, and medical teams to drive continuous improvement and inspection readiness.

Kenntnisse

Leadership

People management

Pharmacovigilance

Regulatory knowledge

Ausbildung

Bachelor's degree in pharmacy

Jobbeschreibung

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).

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 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 in relation to regional projects and activities.
• Support negotiations with health authorities and the review of responses to regulatory agency requests, queries, PSURs, RMPs and local risk minimization tools across the region as needed.
• Champion a strong quality culture across the region and drive continuous improvement in the local implementation of pharmacovigilance procedures, providing regional input to the global process owners who own those procedures.
• Represent pharmacovigilance subject matter expertise at regional and global decision-making forums.
• QPPV Network and Regulatory Engagement
• Run the regional chapter of the QPPV and Local Responsible Person network — convene it, maintain the regional roster of nominated post-holders and their deputies, and ensure GPS deliverables, procedural changes and regulatory updates reach every post-holder in the region.
• Support QPPV and Local Responsible Person post-holders in discharging their own statutory accountabilities, providing region-specific communication and a direct route into GPS.
• Where the role holder personally meets the qualification, experience, residency and language requirements prescribed by a market in the region, they may hold that nomination, subject to a documented assessment that sufficient time is available for both, recorded and reviewed whenever scope changes.
• Ensure that, where national legislation requires a deputy or back-up to the Local QPPV / responsible person, the deputy meets the same qualification requirements as the post-holder, and that the deputization rules are documented in writing, covering responsibilities, handovers and communication channels.
• Ensure the region collectively holds the local language capability required by each market's legislation for its Local QPPV / responsible person and deputy positions, whether through the post-holders themselves or through documented arrangements for that market.
• Ensure a quality-assured translation process is available for pharmacovigilance documentation and communication, in both directions between local languages and English, where post-holders are required to review local product information or correspond with a national authority in a local language.
• Contribute to the development and maintenance of the Pharmacovigilance System Master File (PSMF) and support affiliate customizations.
• Maintain current knowledge of the regulatory environment across the countries in the region, and ensure changes with cross-country or global implications are analyzed and escalated to GPS process owners.
• Establish key relationships within the industry network to gather relevant information that may influence safety activities, and leverage gathered knowledge to improve patient safety.
• Partner with local commercial, medical, regulatory, and marketing teams across the region to ensure pharmacovigilance deliverables are met and safety obligations are integrated into affiliate business activities.
• Local QPPV / Responsible Person Coverage and Health Authority Interface (when applicable)
• Accountable for ensuring that every legally mandated Local QPPV / responsible person position, and every mandated deputy or back-up position, across the hub is filled at all times by a nominated post-holder who meets the qualification, experience, language and residency requirements set by the relevant national legislation.
• Maintain the hub roster of nominated post-holders and deputies; ensure nomination letters, health authority registrations and notifications of change are prepared with the correct signatory and submitted through the correct mechanism within the timelines required in each market.
• Where the role holder personally meets the residency, language, qualification and experience requirements of a market in the hub, they may be nominated as that market’s Local QPPV / responsible person or deputy, and would then discharge the full statutory accountabilities of the position in addition to this role. Any such nomination requires a documented assessment that sufficient time is available for both, recorded and reviewed whenever scope changes.
• Support post-holders within the hub in discharging their own statutory accountabilities — providing a direct route into GPS and the Regional lead, and ensuring GPS deliverables, procedural changes and regulatory updates reach every post-holder in scope.
• Ensure that, where national legislation requires a deputy or back-up to the Local QPPV / responsible person, the deputy meets the same qualification requirements as the post-holder, and that the deputization rules are documented in writing, covering responsibilities, handovers and communication channels.
• Ensure the hub collectively holds the local language capability required by each market's legislation for its Local QPPV / responsible person and deputy positions, whether through the post-holders themselves or through documented arrangements for that market.
• Ensure a quality-assured translation process is available for pharmacovigilance documentation and communication, in both directions between local languages and English, where post-holders are required to review local product information or correspond with a national authority in a local language.
• Establish, maintain and test business continuity and back-up arrangements across the hub covering all pharmacovigilance activities — not only adverse event intake and reporting — including planned and unplanned absence of post-holders and disruption to systems, vendors or alliance partners.
• Oversee interactions with Ministries of Health and national regulatory authorities across the hub on pharmacovigilance matters; ensure a consistent Lilly position across markets, and personally lead engagement on complex, cross-country or escalated matters in coordination with the Regional lead and with Legal, Regulatory, Quality and Medical.
• Ensure the local content and country annexes supplied into the global / EU Pharmacovigilance System Master File (PSMF) are complete, current and internally consistent across the hub, and that any standalone local PSMF or Summary of the Pharmacovigilance System required in a market is maintained; assist the EU QPPV as required.
• Ensure the record of local pharmacovigilance commitments made to health authorities across the hub — RMP and aRMM commitments, additional pharmacovigilance activity (aPVA) and PASS commitments, health authority requests and enquiries, and inspection and audit commitments — is captured in the designated global systems and tracked to closure.
• Ensure local risk-management deliverables across the hub, including country-specific RMPs, local RMP annexes and the local implementation and effectiveness tracking of additional risk-minimization measures, are delivered to global standards and to national timelines.
• Standards, Inspection Readiness, and Quality
• Build a culture of inspection readiness across the region and support affiliate inspections and audits through resource coordination.
• Coordinate and ensure inspection and audit readiness; participate in and oversee aligned affiliate inspections, audits, and assessments.
• Ensure relevant safety standard operating procedures (SOPs) are well understood across all aligned affiliates; lead and provide clarification on local implementation.
• Support the development of global SOPs to ensure alignment with relevant regional and local laws and regulations.
• Ensure globally defined quality systems are implemented and operating effectively across affiliates in the region, and feed regional gaps and failure patterns back to MQO and the relevant GPS process owners.
• Accountable for ensuring pharmacovigilance CAPAs owned within affiliates in the region are completed to the defined quality standards and timelines, supporting affiliate personnel as required.
• Responsible for ensuring compliance with MoH/regulatory authority(ies) requirements and GPS policies, procedures and processes across the region, and for timely communication and escalation of compliance issues to the relevant Global GPS functions and the Medical Quality Organization
• Personal Data Protection
• Act in accordance with privacy policies and other related procedures.

Minimum Qualification Requirements

• Bachelor's degree (or higher) in pharmacy, a medical degree, life science, or health care/pharmaceutical-related field, or equivalent demonstrated experience.
• Minimum 5 years of pharmacovigilance experience in the pharmaceutical industry.
• Demonstrated expertise in the interpretation and application of international regulations related to drug, device safety reporting and strong knowledge of quality systems.
• Demonstrated ability supervising, managing, and leading teams across multiple affiliates or geographies.
• Experience building pharmacovigilance capabilities, both internally and externally with a range of partners.
• Consistently demonstrates strong leadership qualities: effectively communicates cross-functionally, remains flexible, maintains accountability to ensure deliverables/timelines are met, and produces high-quality work on complex problems.
• Regulatory agency inspection experience.
• Demonstrated experience managing pharmacovigilance operations across multiple countries with differing regulatory regimes, languages and business models.
• Where the role holder serves as a Local QPPV / responsible person, or as a nominated deputy, the qualification, experience, residency, language and certification requirements prescribed by the relevant national legislation must also be met, and current evidence of those qualifications maintained.

Other Information / Additional Preferences

• Excellent communication (written and verbal), interpersonal, organizational and negotiation skills.
• Professional knowledge of English including medical terminology.
• Cross-functional networking, relationship development and management.
• Decision making and prioritization.
• Demonstrated ability to innovate and drive successful transformational change.
• Ability to travel as needed (~20%).
• Experience holding, deputizing for, or directly overseeing a Local QPPV or nationally designated responsible person position.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

#WeAreLillyUKandIreland