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.

JOB SUMMARY

The purpose of the Associate Director of North Asia-Pacific (NAPAC) Pharmacovigilance role is to provide leadership and people management for the employees in affiliate pharmacovigilance roles across the NAPAC Hub (Korea, Taiwan, Hong Kong, Macau, Australia and New Zealand) to ensure quality and compliance in pharmacovigilance operations, collaborate with internal and external stakeholders; ensure continuous improvements of processes and implementations of processes and relevant regulations into safety system through comprehensive business and technical knowledge/experience. The Associate Director – NAPAC Pharmacovigilance serves as a link between Global Patient Safety (GPS) and the affiliate safety teams.

JOB RESPONSIBILITIES

1. General Responsibilities and Regulatory Compliance:

Responsible for the establishment and maintenance of Lilly’s local pharmacovigilance (PhV) system, including the performance of the quality system and pharmacovigilance activities to promote, maintain and improve compliance with the legal requirements and relevant Good Vigilance Practice (GVP) requirements in the NAPAC Hub.Provide strategic direction for the execution of pharmacovigilance activities (e.g. adverse event management, expedited and periodic reporting, risk management and creation and maintenance of the Pharmacovigilance System Master File).Evaluate any safety and compliance issues with global management and facilitate execution of corrective and preventive action plan as needed.Acts as an interface between Global Patient Safety (GPS) and NAPAC safety personnelResponsible for appropriate communications between patient safety locally and other stakeholders, GPS, product complaints, medical and regulatory affairs, European Qualified Person for Pharmacovigilance (QPPV), product quality, clinical operations, legal, ethics and compliance and commercial partners.Manage regional communication network; lead regular meetings with NAPAC safety personnel, serve as a key resource for pharmacovigilance within NAPAC.Provide technical expertise to the aligned affiliate and GPS with respect to the interpretation and implementation of relevant pharmacovigilance legislation/regulation for both drugs and devices.Ensure continuity of adverse event (AE) reporting by coordinating back-up personnel during vacation for Pharmacovigilance activities.Ensure relevant stakeholders are made aware of actions initiated for safety reasons for any Lilly product.Review metrics to monitor quality and compliance activities and implement any corrective and or preventative actions.Support review of any local business agreements that require safety and regulatory input (e.g. business alliances, patient support programs, distribution agreements) and ensure required agreements with respect to PhV are in place, up to date and followed as required.Define strategies and lead response to complex technical issues for specific safety aspects in relation to projects, and various activities.Support negotiations with health authorities and the review of responses to regulatory agency requests, queries, PSURs and RMPs and local risk minimization tools as needed.Establish and ensure continuous improvement of global, regional, and local PhV procedures and quality culture.Represent subject matter expertise for pharmacovigilance at high level decision-making.Responsible for optimizing the value of Lilly products through the promotion of patient safety.Establish key relationships within the industry network to gather relevant information that might influence the safety activities and leverage gathered knowledge to improve patient safety.Contribute for policy making activities through identifying and establishing relationship with (such as foundation of pharmacovigilance) key opinion leaders.

2. People Management:

Recruit, train, and develop skilled individuals that are motivated to work with a high-quality standard and achieve department and company objectives.Ensure completion of employee performance objectives and development plans through annual employee performance evaluationsImplement performance management, career management and succession planning to maximize career potential, retain talented people for the long term and maximize value to the corporation.

3. Standards and Inspection Readiness

Coordinate and strive for inspection and audit readiness and participate in affiliate inspections, audits, and assessments.Ensures relevant safety standard operating procedures (SOP) and relevant Business Continuity Plans (BCP) are well understood across the aligned affiliates. Lead, test and provide clarification on local implementation.Supports the development of global SOPs to ensure alignment with relevant laws and regulations.Responsible for ensuring compliance with MoH/regulatory authority(ies) requirements and GPS policies, procedures, and processes.

4. Personal Data Protection:

Act in accordance with respecting privacy and other relating procedures

JOB QUALIFICATIONS

EDUCATION

(Bachelor’s Degree, licenses, and certifications etc.)

Bachelor’s (or higher) degree in pharmacy or medical degree or equivalent demonstrated experience is required.

EXPERIENCE

(Total years of experience related to the position)

10+ years Pharma experience, including 5+ years in Pharmacovigilance (PV), ideally at an above country level.

SOFT SKILLS

(Demonstrated learnings e.g., work effectively under pressure, analytical mindset etc.)

(Maximum 5 soft skills)

Cross-functional workManaging a teamDecision makingProblem solvingAbility to influence

TECHNICAL SKILLS

(Measurable e.g., using MS Office, excellent command of English etc.)

Basic computer skills (Microsoft Word, Excel, PowerPoint)Professional knowledge of English including medical terminologyAdvanced knowledge of global and local PV regulations and legislation, both pre- and post-marketing

OTHER QUALIFICATIONS

(Those required items that are not covered within sections above, e.g., military status, ability to travel etc.)

Excellent communication (written and verbal), interpersonal, organizational and negotiation skillsStrong knowledge of quality systemsAbility to travel as needed

ASSETS

(These are not required to perform the basic functions of the role.)

Knowledge and understanding of local, regional, and global procedures as applicable.Knowledge of legislation with regards to relevant national regulatory guidelines, directives, and regulations in Pharmacovigilance.

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.

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