Sr. Director - GPS Case Management Clinical & Commercial Liaison
Eli Lilly and Company
12 hours ago
Remote friendly (Indianapolis, IN)
United States
Patient Advocacy
Purpose
- Accountable for development of Case Management strategy and standards for safety-related organized data collection in Lilly clinical trials and commercial activities (e.g., patient support programs and market research) in compliance with global regulatory requirements and Lilly compliance policies.
- Oversees Case Management Operations safety data collection strategy across clinical trial and commercial programs; promotes compliance with pharmacovigilance data collection standards and operational consistency for all Lilly products.
- Ensures collaboration between Global Patient Safety (GPS), clinical development teams, commercial operations, call centers, market research programs, and patient support initiatives.
Primary Responsibilities
- Develop and implement strategic plans to standardize adverse event (AE) collection across clinical trials and commercial programs; ensure consistent pharmacovigilance data standards.
- Lead AE collection standardization, innovate technology for improved data capture/quality, and benchmark against industry standards.
- Cross-functionally collaborate with Clinical Development/Commercial, Case Management Operations, GPS Medical Review, Safety Science, Regulatory Affairs, Legal, Compliance, and Tech@Lilly/PV Data and Systems for compliant AE handoff, safety issue management, system optimization, and alignment on regulatory/contractual requirements.
- Advance safety concerns per SOPs; contribute to drug safety documents (e.g., SAE reporting plans, IND/EU annual reports, periodic reports).
- Support business planning for new product launches and internal/external inspections; represent liaison capabilities and resource needs.
- Identify resource needs and manage budget for liaison activities and external training programs.
- Support regulatory inspections/audits (coordination, document preparation, SME).
- Ensure compliant safety reporting language and prepare safety contents for regulatory requests, DMC reports/requests, IB, CRFs, and other submissions.
- Lead interactions with TLAC and other call centers to ensure compliant AE capture/reporting; provide AE training direction for call center staff.
- Establish/monitor AE data quality metrics from customer-facing channels.
- Serve as primary GPS liaison for medical information and clinical operations on AE reporting processes; coordinate responses to complex AE inquiries.
- Oversee pharmacovigilance input to market research program design, reconcile AEs from market research, ensure AE reporting regulatory compliance.
- Provide pharmacovigilance training/guidance to commercial program teams; ensure third-party vendor contracts include appropriate AE reporting provisions.
- Partner with Clinical Development on clinical trial AE reporting requirements, protocol safety reporting procedures, investigator AE training, and safety data transfer to safety databases.
- Oversee GPS input into clinical trial agreements on safety data exchange; collaborate on safety-reporting inspection readiness.
- Recruit/develop/retain a pharmacovigilance-capable workforce; create/manage an agile organization; foster inclusion and innovation; ensure compliance with relevant SOPs/regulations/training.
- Understand and support the EU QPPV role by enabling the Qualified Person to fulfill all legal responsibilities.
Minimum Qualification Requirements
- Bachelor’s degree in a science field.
- 10+ years’ experience in Pharmacovigilance or interconnected areas (e.g., Medical Affairs, Drug Safety Quality, Clinical).
- 3+ years’ experience in people management.
- Experience working in a multicultural virtual global environment.
- Experience in clinical studies and health scientific data.
- Experience leading teams.
Preferred Skills/Experience
- Experience in both clinical development and commercial pharmacovigilance settings.
- Knowledge of global pharmacovigilance regulations (FDA, EMA, ICH).
- Understanding of Good Pharmacovigilance Practices (GVP) and Good Clinical Practices (GCP).
- Experience with call center operations and customer-facing programs.
- Strong relationship management and influencing skills.
- Experience training/supporting cross-functional teams.
- Demonstrated leadership, emotional intelligence, and management skills.
- Background in clinical trial safety reporting and commercial operations.
- Excellent written/verbal communication, interpersonal, organizational, and negotiation skills.
Benefits (explicitly stated)
- Eligibility for a company bonus (depending on company/individual performance).
- Comprehensive benefits including 401(k) participation, pension, vacation; medical/dental/vision/prescription drug; flexible benefits; life insurance; time off/leave; well-being benefits (EAP, fitness benefits, employee clubs/activities).
Application Instructions
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation.
- Accountable for development of Case Management strategy and standards for safety-related organized data collection in Lilly clinical trials and commercial activities (e.g., patient support programs and market research) in compliance with global regulatory requirements and Lilly compliance policies.
- Oversees Case Management Operations safety data collection strategy across clinical trial and commercial programs; promotes compliance with pharmacovigilance data collection standards and operational consistency for all Lilly products.
- Ensures collaboration between Global Patient Safety (GPS), clinical development teams, commercial operations, call centers, market research programs, and patient support initiatives.
Primary Responsibilities
- Develop and implement strategic plans to standardize adverse event (AE) collection across clinical trials and commercial programs; ensure consistent pharmacovigilance data standards.
- Lead AE collection standardization, innovate technology for improved data capture/quality, and benchmark against industry standards.
- Cross-functionally collaborate with Clinical Development/Commercial, Case Management Operations, GPS Medical Review, Safety Science, Regulatory Affairs, Legal, Compliance, and Tech@Lilly/PV Data and Systems for compliant AE handoff, safety issue management, system optimization, and alignment on regulatory/contractual requirements.
- Advance safety concerns per SOPs; contribute to drug safety documents (e.g., SAE reporting plans, IND/EU annual reports, periodic reports).
- Support business planning for new product launches and internal/external inspections; represent liaison capabilities and resource needs.
- Identify resource needs and manage budget for liaison activities and external training programs.
- Support regulatory inspections/audits (coordination, document preparation, SME).
- Ensure compliant safety reporting language and prepare safety contents for regulatory requests, DMC reports/requests, IB, CRFs, and other submissions.
- Lead interactions with TLAC and other call centers to ensure compliant AE capture/reporting; provide AE training direction for call center staff.
- Establish/monitor AE data quality metrics from customer-facing channels.
- Serve as primary GPS liaison for medical information and clinical operations on AE reporting processes; coordinate responses to complex AE inquiries.
- Oversee pharmacovigilance input to market research program design, reconcile AEs from market research, ensure AE reporting regulatory compliance.
- Provide pharmacovigilance training/guidance to commercial program teams; ensure third-party vendor contracts include appropriate AE reporting provisions.
- Partner with Clinical Development on clinical trial AE reporting requirements, protocol safety reporting procedures, investigator AE training, and safety data transfer to safety databases.
- Oversee GPS input into clinical trial agreements on safety data exchange; collaborate on safety-reporting inspection readiness.
- Recruit/develop/retain a pharmacovigilance-capable workforce; create/manage an agile organization; foster inclusion and innovation; ensure compliance with relevant SOPs/regulations/training.
- Understand and support the EU QPPV role by enabling the Qualified Person to fulfill all legal responsibilities.
Minimum Qualification Requirements
- Bachelor’s degree in a science field.
- 10+ years’ experience in Pharmacovigilance or interconnected areas (e.g., Medical Affairs, Drug Safety Quality, Clinical).
- 3+ years’ experience in people management.
- Experience working in a multicultural virtual global environment.
- Experience in clinical studies and health scientific data.
- Experience leading teams.
Preferred Skills/Experience
- Experience in both clinical development and commercial pharmacovigilance settings.
- Knowledge of global pharmacovigilance regulations (FDA, EMA, ICH).
- Understanding of Good Pharmacovigilance Practices (GVP) and Good Clinical Practices (GCP).
- Experience with call center operations and customer-facing programs.
- Strong relationship management and influencing skills.
- Experience training/supporting cross-functional teams.
- Demonstrated leadership, emotional intelligence, and management skills.
- Background in clinical trial safety reporting and commercial operations.
- Excellent written/verbal communication, interpersonal, organizational, and negotiation skills.
Benefits (explicitly stated)
- Eligibility for a company bonus (depending on company/individual performance).
- Comprehensive benefits including 401(k) participation, pension, vacation; medical/dental/vision/prescription drug; flexible benefits; life insurance; time off/leave; well-being benefits (EAP, fitness benefits, employee clubs/activities).
Application Instructions
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation.