Job Description

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 35,000 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\xe2\x80\x99re looking for people who are determined to make life better for people around the world.

General Responsibilities and Regulatory Compliance:

• Execute pharmacovigilance activities as nationally required (e.g. adverse event management, expedited and periodic reporting, risk management and creation and maintenance of the Pharmacovigilance System Master File).
• Understand the role of the Global and/or EU Qualified Person for Pharmacovigilance (QPPV).
• Monitor national pharmacovigilance legislation.
• Ensure appropriate interpretation and implementation of national pharmacovigilance legislation/regulation for both drugs and devices.
• Responsible for liaising with the Ministry of Health (MoH)/national regulatory authority (RA), work with legal, quality, medical and regulatory on safety issues if necessary.
• Responsible for appropriate communication between product safety locally, Global Patient Safety (GPS), and other relevant stakeholders (product complaints, medical and regulatory affairs).
• Ensure and verify that the information contained in Lilly\xe2\x80\x99s Pharmacovigilance System Master File (PSMF) and associated country documents are maintained as applicable.
• Has awareness and provides input to local Risk Management Plans, local risk minimization activities and local Post Safety Authorization Studies as applicable.
• Ensure local business alliance and third-party safety agreements are in place, up to date and followed as required.
• Provide local training (initial and/or refresher) for employees and/or business alliance partners to raise the awareness of PhV, as required.
• Submit other pharmacovigilance documents to the national authority and Ethics Review Board as required (e.g. periodic reports).

Adverse event (AE) management responsibilities:

• Serve as point of contact for reception and collection of AE reports.
• Adverse event/device case entry into the safety database.
• Ensure that all relevant information is captured and forwarded to GPS within the designated timeframe, both for initial and follow-up reports.
• Responsible for the accuracy and completeness of information reported from clinical trial, post marketing study and spontaneous adverse events for marketed products and devices.
• Complete case follow-up as directed or required.
• Responsible for generating and submission of the necessary case reports that are required for expedited reporting to the MoH/RA.
• Reconciliate case reports with business partners, medical information, and product quality.
• Archive case source documentation.

Standards and Inspection Readiness:

• Strive for inspection and audit readiness and participate in aligned affiliate inspections, audits, and assessments.
• Ensure relevant safety standard operating procedures (SOP) are well understood across the affiliate, lead and provide clarification on local implementation where applicable.
• Support the development of global SOPs to ensure alignment with local laws and regulations.
• Help to interpret relevant regulations and guidelines and acts as a contact person in the affiliate.
• Responsible for ensuring compliance with MoH/RA(s) requirements and GPS policies, procedures, and processes.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively \xe2\x80\x9cLilly\xe2\x80\x9d) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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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