Associate Director - Case Management Standards and 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

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Eli Lilly Cork is made up of a talented diverse team of over 2000 employees across 60 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more. Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’ wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.

Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, embRACE, LGBTQ+ & Ally and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.

Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!

The role

The Associate Director - Case Management Standards and Compliance will be responsible for leading the development, implementation, and oversight of robust case management standards and compliance frameworks within Eli Lilly and Company. This role ensures adherence to global regulations, internal policies, and best practices related to pharmacovigilance and product complaint handling, safeguarding patient safety and maintaining regulatory integrity.

This is a 12 month Fixed Term Contract.

Responsibilities

• Lead the design, development, and maintenance of global case management standards, policies, and procedures, incorporating evolving regulatory requirements and industry best practices.
• Oversee the implementation and effectiveness of compliance monitoring programs for case management activities across all relevant functions and regions.
• Conduct regular audits and assessments of case management processes to identify potential compliance gaps, risks, and areas for improvement.
• Develop and deliver comprehensive training programs to ensure all personnel involved in case management activities are proficient in relevant standards, regulations, and systems.
• Act as a subject matter expert on case management compliance, providing guidance and support to internal stakeholders, including Pharmacovigilance, Quality Assurance, and Regulatory Affairs.
• Collaborate with cross-functional teams to investigate and resolve compliance issues, implement corrective and preventive actions (CAPAs), and monitor their effectiveness.
• Represent Eli Lilly during regulatory inspections and audits pertaining to case management, ensuring accurate and timely provision of requested documentation and information.
• Stay abreast of global pharmacovigilance regulations, guidelines, and industry trends to proactively identify and address potential impacts on case management compliance.
• Contribute to the development and enhancement of case management systems and tools to optimize efficiency and ensure compliance.
• Prepare and present regular reports on case management compliance status, key metrics, and identified risks to senior leadership.

Minimum Requirements

• Bachelor's degree in a life science, pharmacy, nursing, or a related field. Advanced degree (Master's, PharmD, PhD) preferred.
• Minimum of 8 years of experience in pharmacovigilance, drug safety, or clinical research, with at least 3 years in a leadership or compliance-focused role.
• In-depth knowledge of global pharmacovigilance regulations and guidelines (e.g., ICH, FDA, EMA, MHRA, PMDA).
• Demonstrated experience in developing, implementing, and overseeing compliance programs in a highly regulated environment.
• Strong understanding of case processing, medical coding (MedDRA, WHODrug), and safety database systems.
• Excellent analytical and problem-solving skills with the ability to identify complex issues and develop effective solutions.
• Proven ability to lead and influence cross-functional teams and stakeholders at various levels.
• Exceptional written and verbal communication skills, including the ability to present complex information clearly and concisely.
• Experience with regulatory inspections and audits is highly desirable.
• Certification in Pharmacovigilance or Regulatory Affairs a plus.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

€72,300 - €106,040

Full-time equivalent employees may also be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees:

• eligibility to participate in a pension plan
• vacation benefits
• eligibility for healthcare benefits
• flexible benefits (if applicable) life insurance and death benefits
• certain time off and leave of absence benefits
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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