Associate Director - Safety Management

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first.

We’re looking for people who are determined to make life better for people around the world.

The purpose of the Associate Director, Safety Management is to provide technical leadership to all areas of the Safety Management organization. This includes providing strategic direction and technical leadership for projects, improvements, and standardization across the group. The Associate Director is the subject matter expert on all technical details related to the inputs, outputs, reporting and oversight of the safety management processes.

• Responsible for alignment of strategy and design of the processes and procedures for safety operations.
• Influence complex regulatory, business or technical issues within a business area and/or function.
• Ownership and expertise of processes across Safety Management.
• Provide consultation to safety management and operations worldwide.
• Provide training, on-boarding, and mentoring to individuals within and outside of the Safety Management group
• Lead projects to simplify and improve work.
• Responsible for cross-functional collaboration to ensure alignment of goals and deliverables.
• Provide responses to regulatory inquiries.
• Serve as the primary functional interface for Safety Management in issue resolution.
• Incorporate industry leading innovative initiatives aimed at improving effectiveness of safety activities.
• Provide subject matter expertise on regulation changes through robust gap assessments and implementation of control measures.
• Lead or participate in high-priority, cross-functional projects and make decisions that impact the function or geography.
• Share product/therapeutic area expertise.

• Develop, implement, and follow internal procedures to ensure compliance and quality of the safety operations processes.
• Leading role during audits and inspections to ensure accurate information is provided as needed.
• Maintain audit and inspection readiness through proactive preparedness activities.

• Support automation of data intake, from cross-functional platforms into system owned by GPS (e.g., MOSAIC, LSS).
• Comprehend interfaces between systems owned by GPS, cross-functional platforms, and regulatory data (e.g., Eudra Vigilance).
• Support configuration / problem resolution of systems and process related to expedited reporting (e.g., E2B).

• Leadership and support of external collaborations (e.g., reviewing agreements, data migrations).
• Oversee monitoring of vendor performance in relation to contracts, regulations, agreed upon procedures.
• Provide input into financial planning efforts in support of budgeting and cost analysis for internal & external sourcing arrangements.
• Review and provide consultation on Business License Agreements/Alliances.
• Provide support and help manage migration activities to ensure compliance is maintained and the appropriate safety data is migrated over.
• Attend Safety Board and/or Safety Team meetings as needed.

• Understand the roles and responsibilities of the European Union Qualified Person for Pharmacovigilance (QPPV).

• Bachelor’s degree in healthcare-related field or life sciences field or demonstrated equivalent experience is required (Pharm
  
  D, BSN, MSN preferred).
• 3+ years of experience within safety management.
• Proven expertise in Pharmacovigilance
• Clinical knowledge of various disease states, human physiology and pharmacology.
• Knowledge of global regulations (e.g.: FDA, EMA GVP) with respect to adverse event and device incident reporting.
• Knowledge and understanding of Global Patient Safety policies and procedures.