"Alerted.org

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.

Purpose:

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.

Technical Leadership

+ 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.

Quality and Compliance Management

+ 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.

Automation, Data Systems and Analytics

+ 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).

External Collaboration

+ 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

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

Minimum Qualification Requirements:

+ Bachelor’s degree in healthcare-related field or life sciences field or demonstrated equivalent experience is required (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 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.

Other Information/Additional Preferences:

+ Previous experience authoring/interpreting SOPs establishing quality systems and delivering training.

+ Project management skills.

+ Demonstrated ability to manage multiple tasks simultaneously.

+ Demonstrated attention to detail and organizational skills.

+ Demonstrated coaching/mentoring skills.

+ Demonstrated ability to identify issues within and across processes, develop solutions and drive implementation of those solutions.

+ Demonstrated leadership by influence, including ability to negotiate appropriately and effectively across teams.

+ English language skills – fluent written and verbal communications, effective communication skills.

+ Basic computer skills (Microsoft Word, Excel, Windows).

+ This role is based in Indianapolis, IN and relocation is provided.

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 is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

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

$111,000 - $162,800

Full-time equivalent employees also will 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, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and 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.

\#WeAreLilly