Pharmacovigilance Associate

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.

POSITION PURPOSE

The role of Associate PHV within at Eli Lilly company is crucial for ensuring our medicines safety. The ideal candidate collects and evaluates safety data on medications, identifying and analyzing adverse reactions. Additionally, she/he ensure that all activities comply with current regulations. Communication with healthcare professionals and authorities is essential to maintain high safety standards. This role requires attention to detail, Strong communication skills both verbal and written,  analytical skills, ability to manage multiple tasks simultaneously and a good understanding of pharmacovigilance regulations.

RESPONSIBILITIES

The ideal candidate will have the following responsibilities:

• Serve as point of contact for reception and collection and management of AE reports ensuring that all relevant information is captured and forwarded to Global Patient Safety (GPS) within the designated timeframe
• Complete case follow-up as directed or required
• Strive for inspection and audit readiness and participate in aligned affiliate inspections, audits, and assessments
• Support the development of global SOPs to ensure alignment with local laws and regulations
• 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, GPS, and other relevant stakeholders (product complaints, medical and regulatory affairs).
• Ensure and verify that the information contained in Lilly’s 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 and reconciliate case reports with business partners
• 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.

ESSENTIAL REQUIREMENTS

• Bachelor’s degree in a health profession or life science field
• At least 2 years of experience in a Pharmacovigilance department or similar roles (e.g. Regulatory)
• Knowledge of legislation with regards to relevant national regulatory guidelines, directives and regulations in Pharmacovigilance.

• Professional knowledge of English including medical terminology.
• Strong knowledge of quality systems.

INTERNAL AND EXTERNAL RELATIONS

• Continuous collaboration with the Brand Team, Affiliate Quality, Regulatory, and all the customer facing functions
• Integration and collaboration with GPS structure

ADDITIONAL INFORMATION

• In collaboration with the Pharmacovigilance team ensure broad coverage of the pharmacovigilance service throughout the year.

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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