Associate Director - Safety Management at Eli Lilly and Company

Indianapolis, Indiana, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Bachelor’s degree in healthcare-related field or life sciences field or demonstrated equivalent experience (PharmD, 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 the roles and responsibilities of the European Union Qualified Person for Pharmacovigilance (QPPV)

Responsibilities

Provide technical leadership to all areas of the Safety Management organization, including strategic direction and technical leadership for projects, improvements, and standardization
Serve as the subject matter expert on all technical details related to the inputs, outputs, reporting and oversight of the safety management processes
Align strategy and design processes and procedures for safety operations
Influence complex regulatory, business or technical issues within a business area and/or function
Own and provide expertise on 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
Lead 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., EudraVigilance)
Support configuration / problem resolution of systems and process related to expedited reporting (e.g., E2B)
Provide 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
Perform other related duties, as assigned

Skills

Key technologies and capabilities for this role

Safety ManagementRegulatory ComplianceProcess ImprovementTechnical LeadershipProject ManagementCross-Functional CollaborationRisk AssessmentTraining & MentoringGap AnalysisStrategic Planning

Questions & Answers

Common questions about this position

What is the employment type for this position?

This is a full-time position.

Is this role remote or does it require working from a specific location?

This information is not specified in the job description.

What key skills and responsibilities are required for the Associate Director role?

The role requires technical leadership in safety management processes, expertise in regulatory compliance, cross-functional collaboration, automation and data systems knowledge, and experience leading audits, inspections, and high-priority projects.

What is the company culture like at Eli Lilly?

Eli Lilly emphasizes uniting caring with discovery to make life better, putting people first, giving best effort to work, and contributing to communities through philanthropy and volunteerism.

What makes a strong candidate for this Associate Director position?

Strong candidates will have expertise as a subject matter expert in safety management processes, proven technical leadership, experience influencing regulatory and technical issues, and skills in cross-functional collaboration, automation, and compliance management.

Eli Lilly and Company

Develops and delivers prescription medicines globally

About Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.

Indianapolis, IndianaHeadquarters

1876Year Founded

$1,180.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Competition from Novo Nordisk's Ozempic may impact tirzepatide's market share.

Potential construction delays in Indiana could affect GLP-1 drug production timelines.

Regulatory challenges may hinder Kisunla's expansion in new Alzheimer's markets.

Differentiation

Eli Lilly's rich history includes the first life-saving insulin treatment.

Lilly's strategic partnerships enhance its position in neurodegenerative disease treatments.

FDA approval of Zepbound opens new therapeutic markets for sleep disorder treatments.

Upsides

Lilly's $9 billion complex in Indiana boosts GLP-1 drug production capacity.

Kisunla's approval in China expands Lilly's Alzheimer's treatment market in Asia.

Collaboration with EVA Pharma enhances Lilly's reputation as socially responsible.

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