Senior Director, Drug Safety Operations (remote)

Eli Lilly and Company; Boston (MA); Remote; USD 161,000 - 260,000; Full time

Job summary

Centessa Pharmaceuticals is seeking a Senior Director, Drug Safety Operations to lead global pharmacovigilance activities across clinical programs. This remote US-based role demands strategic leadership, expert safety data handling, and strong vendor governance.

You will ensure compliance with FDA/EMA/ICH GVP standards, drive KPI-driven improvements, and support inspections while collaborating with safety physicians and cross-functional teams.

Qualifications

• Significant pharmacovigilance operations experience.
• Experience managing global safety operations and ICSR processing.
• Deep knowledge of FDA/EMA/MHRA/ICH GVP guidelines.

Responsibilities

• Lead Drug Safety Operations activities across clinical programs.
• Partner with safety leadership to implement governance and resourcing.
• Oversee ICSR processing, SUSAR reporting, and regulatory submissions.
• Ensure inspection readiness and support regulatory audits.
• Manage vendor relationships and external partners for quality and cost.
• Drive KPIs and continuous improvement in safety operations.

Skills

Pharmacovigilance

Drug Safety Operations

GxP compliance

Regulatory submissions

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences

Advanced degree (PharmD, MSN, MPH, or MS)

Tools

Argus

ArisG

MedDRA

Job description

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.

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). In addition, Lilly offers a comprehensive benefit program to eligible employees, 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; and 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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