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.
General Responsibilities and Regulatory Compliance:
Fulfil the legal and regulatory requirements for the QPPV responsible for pharmacovigilance role as defined by legislation and/or guidelines in the respective country(ies) of the region.
Responsible for the establishment and maintenance of Lilly’s local pharmacovigilance 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 region.
Understand pharmacovigilance activities (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 European Qualified Person for Pharmacovigilance (EU QPPV).
Escalate any safety and compliance issues to appropriate local and global management.
Acts as an interface between Global Patient Safety (GPS) and the aligned affiliate.
Responsible for appropriate communications between patient safety locally and other stakeholders, GPS, product complaints, medical and regulatory affairs.
Provide technical expertise to the aligned affiliate and GPS with respect to the interpretation and implementation of national pharmacovigilance legislation/regulation for both drugs and devices.
As necessary, ensure appropriate backup coverage is in place in times of absence or unavailability.
Ensure relevant stakeholders are made aware of actions initiated for safety reasons for any Lilly product.
Lead, coordinate and organize all necessary training on adverse reporting to the aligned affiliate as appropriate.
Review metrics to monitor quality and compliance activities and implement any corrective and or preventative actions.
Responsible for the review and approval of any local business agreements that require safety and regulatory input (such as: business alliances, patient support programs, distribution agreements).
Collaborate with external customers and be an active participant of the local pharmacovigilance industry association groups.
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
Serve as point of contact for reception and collection of AE reports.
Adverse event case entry into the safety database, complete case follow-up as directed or required.
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.
Reconciliate case reports with business partners, medical information, and product quality.
People Management:
Recruit, train and develop skilled individuals that are motivated to work with a high-quality standard and achieve department and company objectives.
Implement performance management, career management and succession planning to maximize career potential, retain talented people for the long term and maximize value to the corporation.
Standards and Inspection Readiness:
Coordinate and strive for inspection and audit readiness and participate in affiliate inspections, audits and assessments.
Ensure relevant safety standard operating procedures (SOP) are well understood across the aligned affiliate; lead and provide clarification on local implementation.
Support the development of global SOPs to ensure alignment with local laws and regulations.
Responsible for ensuring compliance with MoH/regulatory authority(ies) requirements and GPS policies, procedures and processes.
Minimum Qualification Requirements:
Bachelor’s degree in a health profession (Pharmacy or Physician)
2 years of experience in drug safety, pharmacovigilance
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.
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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