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POSITION PURPOSE

This job description describes pharmacovigilance activities at the affiliates. The exact role name can vary depending on local human resource (HR) requirements. This role does not have line management responsibilities. The responsibilities are generally the same even though titles may vary.

The purpose of the role is to ensure affiliate compliance with internal and external requirements concerning Pharmacovigilance (PhV) in aligned countries. In the absence of primary PhV role the PhV back-up shall take up key responsibilities described in this document.

Key Responsibilities:

General Responsibilities and Regulatory Compliance:

Execute pharmacovigilance activities as nationally required (such as: adverse event management, expedited and periodic reporting, risk management and creation and maintenance of the Pharmacovigilance System Master File).Understand the role of the AU Qualified Person for Pharmacovigilance.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’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.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 (such as: 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.

Standard 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.

Minimum qualification requirements

Bachelor’s degree in a health profession (such as: Pharmacy, Nursing) or life science field or equivalent demonstrated experience in patient safety.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.

Other information / additional preferences:

Excellent communication (written and verbal), interpersonal, organizational and negotiation skills.Professional knowledge of English including medical terminology.Strong knowledge of quality systems.

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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