Pharmacovigilance Associate At Lilly
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’re looking for people who are determined to make life better for people around the world.
NEA Pharmacovigilance Associate
The purpose of the NEA Pharmacovigilance Associate role is to execute the operational aspects of Pharmacovigilance support on Lilly’s behalf for the strategic business partners who are Marketing Authorization Holders for Lilly products in NEA region, including:
Partner Oversight: Provide operational excellence to support Partner QPPV and QPPV Backup, assist to monitor progress and provide Lilly support as necessary.
Safety Database Management: Adverse event case entry into the safety database. Maintain data in Lilly systems and electronic archives
Support Partner with required Pharmacovigilance documents to ensure the local Ministry of Health (MoH)/ Regulatory Authority (RA) requirements are fulfilled with timelines agreed with the Partner.
General Responsibilities and Regulatory Compliance:
Understand the role of the Global and/or EU Qualified Person for Pharmacovigilance (QPPV) and assist as required.
Support implementation of local quality system in line with the global quality system and local regulations.
Support internal audits / assessments / self-inspections in collaboration with Regulatory and Quality personnel.
Raise awareness on compliance issues with leadership and relevant functions.
As necessary, ensure that any changes to the details of the Local QPPV are notified promptly to the Global QPPV and or EU QPPV.
Ensure and verify that the information contained in Lilly’s European Pharmacovigilance System Master File (EU 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.
Interact and escalate as necessary safety issues with Partner and GPS.
Ensure local business alliance and third-party safety agreements are in place, up to date and followed as required.
Ensures periodic reports and other Pharmacovigilance documents are submitted as applicable.
Partner Oversight and support:
Participate in Alliance (Pharmacovigilance related) Meetings.
Serve as affiliate pharmacovigilance point person for queries from Global Patient Safety (GPS), Global and/or EU QPPV and other relevant stakeholders (product complaints, medical, and regulatory affairs) to ensure compliance with safety obligations.
Conduct routine oversight and keep track of performance metrics, via regular interactions with the Partner(s).
Work with global Lilly functions to obtain all required submission documents and timely responses to Regulatory Authority requests received from the Partner.
Provide submission documents to Partner as per agreed timelines.
Archive External Party Management documentation.
Adverse Event (AE) Management Responsibilities:
Serve as point of contact for reception and collection of AE reports from Partner as well as other sources, if applicable.
Adverse event 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 surveillance study and spontaneous adverse events for marketed products and devices, as applicable.
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. Act as point of contact when required.
Ensure relevant safety standard operating procedures (SOP) are well understood across the affiliate/ partner; 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:
Minimum requirements as defined by legislation or Bachelor degree in a health profession (i.e. 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.
Strong knowledge of quality systems.
Professional knowledge of English including medical terminology