Associate Director / Director - Regional Pharmacovigilance Leader (Americas)

Eli Lilly and Company•Us, IN

21h

About The Position

The Associate Director / Director, Regional Pharmacovigilance role provides operational and people leadership for pharmacovigilance activities across the aligned regional hub. The role translates global pharmacovigilance strategy into consistent regional execution, works with other regional PV leaders to share learnings, and ensures quality, compliance, consistency, and continuous improvement across affiliates. It is the primary connection between affiliate safety personnel, Global Patient Safety (GPS), Qualified Persons for Pharmacovigilance (QPPVs), and the Medical Quality Organization (MQO). The role leads affiliate-level pharmacovigilance professionals, integrates pharmacovigilance capabilities across functions, and represents the region in GPS governance and strategy. Holding a Local QPPV or responsible-person nomination is not a core expectation; it may be held when the role holder meets applicable market requirements and a documented assessment confirms sufficient time is available. The role is accountable for ensuring legally required nominations are filled, qualified, and supported. The position leads, develops, and motivates regional personnel; ensures appropriate onboarding, training, accreditation, performance management, and succession planning; and works with affiliate leadership and GPS to resolve operational issues. It is accountable for adequate qualified coverage across assigned countries, workforce-planning input aligned with the global budget and resourcing strategy, and engagement with local General Managers and Medical Directors on pharmacovigilance obligations. The role operates and maintains the regional pharmacovigilance system and implements global strategy and processes across affiliates. It provides oversight of adverse-event management, expedited and periodic reporting, risk management, Pharmacovigilance System Master File (PSMF) content, business continuity, vendor performance, agreements, quality metrics, remediation, and corrective and preventive actions. It provides technical and regulatory expertise across drug and device pharmacovigilance, manages regional communications, maintains external stakeholder relationships, and contributes to regulatory intelligence and policy development. The role runs the regional QPPV and Local Responsible Person network, maintains post-holder and deputy rosters, supports statutory accountabilities, and ensures local language capability and quality-assured translation arrangements where required. Where applicable, it oversees Local QPPV/responsible-person coverage, health authority notifications and interactions, local PSMF content, commitments to authorities, and local risk-management deliverables. It promotes inspection readiness, coordinates affiliate inspections and audits, supports SOP implementation and development, and ensures regional quality systems and CAPAs meet required standards and timelines. Travel as needed is approximately 20%.

Requirements

Bachelor's degree or higher in pharmacy, medicine, life science, a health care/pharmaceutical-related field, or equivalent demonstrated experience.
At least 5 years of pharmacovigilance experience in the pharmaceutical industry.
Experience supervising, managing, and leading teams across multiple affiliates or geographies.
Experience building pharmacovigilance capabilities internally and externally with a range of partners.
Strong leadership, cross-functional communication, flexibility, accountability for deliverables and timelines, and ability to produce high-quality work on complex problems.
Regulatory agency inspection experience.
Excellent written and verbal communication, interpersonal, organizational, and negotiation skills.
Professional knowledge of English, including medical terminology.
Expertise interpreting and applying international regulations related to drug and device safety reporting, and strong knowledge of quality systems.
Cross-functional networking and relationship development and management skills.
Experience managing pharmacovigilance operations across multiple countries with differing regulatory regimes, languages, and business models.
Decision-making and prioritization skills.
Demonstrated ability to innovate and drive successful transformational change.
Ability to travel as needed, approximately 20%.
If serving as a Local QPPV/responsible person or nominated deputy, must meet the relevant national legislative qualification, experience, residency, language, and certification requirements and maintain current evidence.

Nice To Haves

Experience holding, deputizing for, or directly overseeing a Local QPPV or nationally designated responsible-person position.

Responsibilities

Lead, develop, and motivate regional pharmacovigilance personnel, including setting objectives, development plans, training, performance management, career management, and succession planning.
Ensure personnel complete onboarding, role-specific training, and locally required accreditation before assuming responsibilities, with inspection-ready records.
Work with affiliate leadership and GPS to resolve regional operational issues and escalate matters requiring global decisions or process changes.
Ensure adequate qualified pharmacovigilance coverage across assigned countries, including required Local QPPV/responsible-person and deputy nominations, and ensure changes are notified to health authorities promptly.
Provide regional input into workforce planning and capacity management aligned with the global pharmacovigilance budget and resourcing strategy.
Engage local General Managers and Medical Directors to ensure pharmacovigilance obligations are understood and supported, and escalate local safety matters appropriately.
Operate and maintain the regional pharmacovigilance system and translate global strategy into a regional execution plan.
Oversee regional pharmacovigilance activities, including adverse-event management, expedited and periodic reporting, risk management, and PSMF creation and maintenance, including obligations under license-partner and business-alliance agreements.
Drive adoption and consistent implementation of global pharmacovigilance processes; identify regional efficiency and improvement opportunities and share them with global process owners.
Evaluate safety and compliance issues with global management and facilitate corrective and preventive action plans.
Serve as the primary interface between GPS and regional affiliate safety personnel; manage regional communications, lead regular safety meetings, and provide pharmacovigilance expertise.
Maintain relationships with external regional stakeholders, including industry associations, professional bodies, pharmacovigilance networks, and key opinion leaders; gather regulatory intelligence and contribute to policy development.
Provide technical expertise on pharmacovigilance legislation and regulations for drugs and devices across regional jurisdictions.
Establish and maintain regional business continuity plans for all pharmacovigilance activities, including deputy arrangements and contingencies for system, vendor, and alliance-partner disruption.
Ensure relevant stakeholders are informed of safety actions for Lilly products, including drugs and devices.
Monitor regional quality and compliance metrics, investigate gaps, drive remediation and CAPAs to closure, and report findings and systemic issues to global owners.
Support review of local business agreements requiring safety and regulatory input and ensure required pharmacovigilance agreements are current and followed.
Oversee regional vendor and service-provider performance under the centrally owned vendor-governance model.
Lead responses to complex technical issues related to regional safety projects and activities; support health-authority negotiations and review of agency responses, queries, PSURs, RMPs, and local risk-minimization tools as needed.
Champion quality and continuous improvement in local implementation of pharmacovigilance procedures and represent pharmacovigilance expertise at regional and global decision-making forums.
Convene and run the regional QPPV and Local Responsible Person network, maintain post-holder and deputy rosters, and ensure GPS deliverables, procedural changes, and regulatory updates reach all post-holders.
Support QPPV and Local Responsible Person post-holders in their statutory accountabilities and provide region-specific communication and a direct route into GPS.
Ensure required deputies meet qualification requirements and that deputization rules, handovers, and communication channels are documented.
Ensure regional language capability and quality-assured translation processes are available where required by local legislation or duties.
Contribute to development and maintenance of the PSMF and support affiliate customizations.
Monitor regulatory changes across regional countries and analyze and escalate changes with cross-country or global implications.
Partner with local commercial, medical, regulatory, and marketing teams to deliver pharmacovigilance requirements and integrate safety obligations into affiliate activities.
When applicable, ensure legally mandated Local QPPV/responsible-person and deputy positions are continuously filled by qualified, experienced, language-capable, and resident nominees.
Maintain nomination rosters and ensure nomination letters, health-authority registrations, and change notifications are prepared and submitted correctly and on time.
When applicable, oversee Ministry of Health and national regulatory authority interactions, coordinate consistent positions across markets, and lead complex or escalated matters with relevant functions.
Ensure local PSMF content and country annexes are complete, current, and consistent; maintain standalone local PSMFs or system summaries where required and assist the EU QPPV as needed.
Track local pharmacovigilance commitments to health authorities, including RMP/aRMM, aPVA, PASS, requests, enquiries, and inspection or audit commitments, through designated global systems to closure.
Ensure local risk-management deliverables, including country-specific RMPs, local annexes, and implementation and effectiveness tracking of additional risk-minimization measures, meet global standards and national timelines.
Build inspection readiness and coordinate support for affiliate inspections and audits; participate in and oversee inspections, audits, and assessments.
Ensure safety SOPs are understood across affiliates and clarify local implementation; support global SOP development to align with regional and local requirements.
Ensure global quality systems are implemented effectively across regional affiliates and communicate gaps and failure patterns to MQO and GPS process owners.
Ensure affiliate-owned pharmacovigilance CAPAs are completed to required quality standards and timelines, and communicate or escalate compliance issues promptly.

Benefits

Company bonus, depending in part on company and individual performance.
Eligibility to participate in a company-sponsored 401(k).
Pension.
Vacation benefits.
Eligibility for medical, dental, vision, and prescription drug benefits.
Flexible benefits, including healthcare and/or dependent day-care flexible spending accounts.
Life insurance and death benefits.
Certain time-off and leave-of-absence benefits.
Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.
Employee resource groups that provide support networks and are open to all employees.