Senior Director, Drug Safety Operations (remote)

Eli Lilly and Company; Stati Uniti; Remoto; USD 161.000 - 260.000; Tempo pieno

Vantaggi offerti da questo lavoro

401(k)

Pension

Vacation benefits

Medical, dental, vision benefits

Flexible benefits

Life insurance

Leave of absence benefits

Well-being programs

Descrizione del lavoro

Eli Lilly and Company seeks a Senior Director, Drug Safety Operations to lead global safety and pharmacovigilance across development programs. This role reports to the AVP and drives end-to-end safety operations, case processing, regulatory reporting, and vendor oversight.

You will build and mentor a high-performing team, drive KPIs, and partner across functions to align pharmacovigilance with program objectives. This is a remote US role with occasional travel and a competitive benefits package.

Competenze

• Bachelor’s degree in Life Sciences or related field and 10+ years in pharmacovigilance operations.
• Experience leading global safety operations, case processing, and regulatory submissions.
• Knowledge of FDA/EMA/ICH guidelines and vendor governance.

Mansioni

• Lead Drug Safety Operations activities and manage team members to ensure timely, accurate safety information processing.
• Partner to implement operational processes, governance, and resourcing for development portfolios.
• Oversee pharmacovigilance vendors and ensure regulatory compliance and performance management.
• Drive inspection readiness and CAPA programs across global PV activities.
• Collaborate with cross-functional partners to align safety operations with program goals.

Conoscenze

Cross-functional collaboration

Communication

Stakeholder management

Formazione

Bachelor’s degree in Life Sciences or related field

Advanced degree (PharmD / MPH / MS)

Strumenti

Pharmacovigilance systems (Argus / ArisG)

Descrizione del lavoro

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.

Overview

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is a clinical-stage company developing orexin receptor 2 (OX2R) agonists as a new class of medicines for the treatment of narcolepsy and potentially other sleep-wake disorders. Centessa’s lead investigational candidate – cleminorexton (formerly ORX750) – is being developed for narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia. Centessa's OX2R agonist portfolio includes additional clinical and preclinical-stage assets with potential utility across a broader range of neurological, neurodegenerative, and neuropsychiatric conditions. Headquartered in Boston, Massachusetts, Centessa was recognized as a Great Place to Work® in 2026.

Senior Director, Drug Safety Operations

We are seeking a highly experienced and detail-oriented Senior Director, Drug Safety Operations to lead and optimize the operational aspects of our global safety and pharmacovigilance (PV) function. Reporting to the AVP, Drug Safety & Pharmacovigilance, this role will provide strategic and operational leadership for our global drug safety and pharmacovigilance function. This role is responsible for overseeing end-to-end safety operations, including case processing, individual case safety report (ICSR) management, regulatory reporting, vendor oversight, inspection readiness, and compliance with global pharmacovigilance requirements across the product lifecycle.

Responsibilities

• Lead Drug Safety Operations activities and manage assigned team members, ensuring the timely, accurate, and compliant collection, assessment, processing, review, and reporting of safety information across clinical development programs.
• Partner across the Drug Safety leadership team to implement and enhance operational processes, governance activities, and resourcing plans in support of an evolving development portfolio.
• Lead execution of the global Drug Safety Operations strategy, operating model, governance framework, objectives, and resourcing plans to support an evolving portfolio and business priorities.
• Oversee pharmacovigilance operations, including case intake, triage, processing, medical coding, quality review, Individual Case Safety Reports (ICSRs), SUSAR reporting, and submissions to global regulatory authorities.
• Lead oversight and governance of pharmacovigilance vendors, CROs, safety database providers, and other external partners, ensuring high-quality service delivery, regulatory compliance, performance management, and financial stewardship.
• Establish, maintain, and continuously improve pharmacovigilance processes, SOPs, work instructions, quality systems, and operational controls to ensure compliance with global regulations and industry standards, including FDA, EMA, MHRA, PMDA, and ICH requirements.
• Ensure ongoing inspection readiness and lead operational support for regulatory inspections, partner audits, and quality assessments, including CAPA development and implementation as needed.
• Monitor operational performance through KPIs, quality metrics, dashboards, and trend analyses to drive data-informed decision-making, accountability, and continuous improvement.
• Partner cross-functionally with Drug Safety physicians, Clinical Development, Regulatory Affairs, Quality, Medical Affairs, Biometrics, and external partners to align pharmacovigilance operations with program and corporate objectives.
• Support the preparation and operational execution of aggregate safety reporting activities, including DSURs, PBRERs, Risk Management Plans, and other regulatory deliverables, ensuring data integrity and inspection-ready documentation.
• Drive operational excellence through process optimization, system enhancements, automation, and scalable solutions that improve efficiency, quality, compliance, and organizational effectiveness.
• Build, develop, and mentor a high-performing Drug Safety Operations team while fostering a culture of accountability, collaboration, innovation, and patient focus.

Basic Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Public Health, or a related scientific discipline.
• 10+ years of pharmacovigilance and drug safety operations experience within the biotechnology and/or pharmaceutical industry, including increasing levels of responsibility.
• Experience supporting small molecule development programs and/or neuroscience/CNS products within an emerging biotechnology environment strongly preferred.
• Demonstrated experience managing global safety operations, including case processing, Individual Case Safety Reports (ICSRs), SUSAR reporting, and regulatory submissions within a GxP-regulated environment.
• Strong knowledge of global pharmacovigilance regulations and guidance, including FDA, EMA, MHRA, ICH, GVP, and applicable international reporting requirements.
• Experience overseeing pharmacovigilance vendors, CROs, and external service providers, including performance management, governance, and compliance oversight.
• Hands-on experience with safety databases and pharmacovigilance technologies (e.g., Argus, ArisG, or comparable systems), including familiarity with MedDRA, WHO Drug dictionaries, and E2B(R3) reporting standards.
• Experience supporting clinical-stage development programs, with knowledge of aggregate safety reporting activities such as DSURs, PBRERs, Risk Management Plans, and related regulatory deliverables.
• Proven ability to lead and develop staff, manage competing priorities, and operate effectively in a fast-paced, evolving biotech environment.
• Strong cross-functional collaboration, communication, and stakeholder management skills, with the ability to work effectively across geographies and organizational levels.
• Experience supporting regulatory inspections, audits, and health authority interactions, with a demonstrated commitment to quality, compliance, and patient safety.

Preferred Qualifications

• Advanced degree (e.g., PharmD, MSN, MPH, or MS) in a related scientific discipline.

Work Location

The Senior Director, Drug Safety Operations role is a remote position based in the US, with occasional travel.

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 is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $160,500 - $259,600.

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

• including eligibility to participate in a company-sponsored 401(k)
• pension
• vacation benefits
• eligibility for medical, dental, vision and prescription drug benefits
• flexible benefits (e.g., 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 (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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