Senior Director, Drug Safety Operations

Eli Lilly and Company; Hyderabad; Presencial; INR 2.500.000 - 4.000.000; Jornada completa

Descripción de la vacante

Eli Lilly and Company in Hyderabad seeks a senior professional to lead Drug Safety Operations, ensuring timely and compliant safety reporting across development programs. You will drive governance, optimize resourcing, and manage external partners to deliver high-quality pharmacovigilance services.

The role requires 10+ years in pharmacovigilance with a strong track record in safety operations, SOPs, and inspections readiness, including DSURs and PBRERs.

Formación

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, Public Health, or related field.

Responsabilidades

• Lead Drug Safety Operations activities and ensure timely, compliant ICSR processing and reporting.
• Partner with Drug Safety leadership to optimize processes, governance, and resourcing.
• Oversee pharmacovigilance operations, including case intake, medical coding, SUSAR reporting, and submissions.
• Manage vendors, CROs, safety databases, and external partners for quality and compliance.
• Establish and improve SOPs, quality systems, and operational controls to meet global regulations.
• Support regulatory inspections and audits, including CAPA development.
• Monitor KPIs and dashboards to drive data-informed decisions.
• Collaborate with cross-functional teams to align pharmacovigilance with programs.
• Support aggregate safety reporting activities (DSURs, PBRERs, Risk Management Plans).

Conocimientos

Pharmacovigilance

Drug Safety Operations

Leadership

Vendor Management

Educación

Bachelor's degree in Life Sciences / related field

Descripción del empleo

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.

Qualification & Experience

• 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.