Associate Director, Global Case Management Compliance

Eli Lilly and Company; Ireland; Hybrid; EUR 72,000 - 106,000; Full time

Benefits offered by this job

Flexible hybrid working

Healthcare benefits

Pension

Life assurance

Subsidised canteen

On-site gym

Travel subsidies

On-site parking

Job summary

Eli Lilly Cork, part of Eli Lilly and Company, seeks an Associate Director to lead the development and oversight of global case management standards and compliance frameworks, safeguarding patient safety and regulatory integrity. This 12-month fixed-term contract requires extensive pharmacovigilance leadership and cross-functional collaboration.

The role emphasizes regulatory adherence, training programs, and ongoing process improvement across regions, with opportunities to influence inspections

Qualifications

• Bachelor's degree in life science or related field; advanced degree preferred.
• 8+ years in pharmacovigilance, drug safety, or clinical research; 3+ years in leadership/compliance.
• Knowledge of global pharmacovigilance regulations (ICH, FDA, EMA, MHRA, PMDA).

Responsibilities

• Lead the design, development, and maintenance of global case management standards, policies, and procedures.
• Oversee the implementation and effectiveness of compliance monitoring programs for case management activities across functions and regions.
• Conduct regular audits and assessments to identify compliance gaps, risks, and improvement areas.
• Develop and deliver training programs on standards, regulations, and systems.
• Act as SME on case management compliance for Pharmacovigilance, QA, and Regulatory Affairs.
• Collaborate with cross-functional teams to resolve compliance issues and implement CAPAs.
• Prepare for regulatory inspections and audits with timely documentation.

Skills

Pharmacovigilance

Regulatory compliance

Leadership

Cross-functional collaboration

Analytical thinking

Education

Bachelor's degree in life sciences

Advanced degree (Master's, PharmD, PhD) preferred

Tools

MedDRA

WHODrug

Safety database systems

Job description

Eli Lilly Cork, part of Eli Lilly and Company, seeks an Associate Director to lead the development and oversight of global case management standards and compliance frameworks, safeguarding patient safety and regulatory integrity. This 12-month fixed-term contract requires extensive pharmacovigilance leadership and cross-functional collaboration.

The role emphasizes regulatory adherence, training programs, and ongoing process improvement across regions, with opportunities to influence inspections