Senior Director, Drug Safety Operations

🕒 5 days ago

🇺🇸 United States – Remote

💵 $160.5k - $259.6k / year

⏰ Full Time

🟠 Senior

⚙️ Operations

👻 Ghost score 0%

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Eli Lilly and Company

WebsiteLinkedInAll Job Openings

10,000+ employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

💰 $6.5M Post-IPO Debt - Eli Lilly on 2024-02

Pharmaceuticals • Healthcare • Biotechnology

Eli Lilly and Company is a multinational pharmaceutical company that researches, develops, manufactures, and markets prescription medicines across multiple therapeutic areas including diabetes, oncology, immunology, neuroscience, and pain. Headquartered in Indianapolis, Indiana, Lilly is known for its extensive R&D, clinical development, and global commercialization of biologic and small-molecule drugs. The company focuses on drug discovery, clinical trials, regulatory approvals, and large-scale pharmaceutical manufacturing and distribution.

📋 Description

• Lead Drug Safety Operations activities and manage assigned team members • Ensure timely, accurate, and compliant collection, assessment, processing, review, and reporting of safety information across clinical development programs • Partner with Drug Safety leadership to implement and enhance operational processes, governance activities, and resourcing plans • Lead execution of the global Drug Safety Operations strategy, operating model, governance framework, objectives, and resourcing plans • Oversee case intake, triage, processing, medical coding, quality review, ICSRs, SUSAR reporting, and submissions to global regulatory authorities • Lead oversight and governance of pharmacovigilance vendors, CROs, safety database providers, and external partners • Establish and improve pharmacovigilance processes, SOPs, work instructions, quality systems, and operational controls • Ensure inspection readiness and support regulatory inspections, partner audits, and quality assessments, including CAPA development and implementation • Monitor KPIs, quality metrics, dashboards, and trend analyses to drive continuous improvement • Collaborate with Drug Safety physicians, Clinical Development, Regulatory Affairs, Quality, Medical Affairs, Biometrics, and external partners • Support aggregate safety reporting, including DSURs, PBRERs, Risk Management Plans, and other regulatory deliverables • Drive process optimization, system enhancements, automation, and scalable solutions • Build, develop, and mentor a high-performing Drug Safety Operations team

🎯 Requirements

• 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, such as Argus, ArisG, or comparable systems • Familiarity with MedDRA, WHO Drug dictionaries, and E2B(R3) reporting standards • Experience supporting clinical-stage development programs and 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 across geographies and organizational levels • Experience supporting regulatory inspections, audits, and health authority interactions • Advanced degree such as PharmD, MSN, MPH, or MS in a related scientific discipline preferred

🏖️ Benefits

• Company bonus depending partly on company and individual performance • Company-sponsored 401(k) • Pension • Vacation benefits • Medical, dental, vision, and prescription drug benefits • Flexible benefits, including healthcare and/or dependent day care flexible spending accounts • Life insurance and death benefits • Time off and leave of absence benefits • Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities • Remote work with occasional travel