Senior 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.

The purpose of the Jr./Sr. Pharmacovigilance Associate role is to support strategic business partners (BPs) who are Marketing Authorization Holders on Lilly’s behalf in the respective countries of Russia and Commonwealth of Independent States (CIS) (except for Azerbaijan), and SAMETA (South Asia, Middle East, Turkey and Africa) countries to execute the operational aspects of Pharmacovigilance (PhV) including the BP oversight activities and support PhV related processes and procedures in the region to ensure regulatory compliance for expedited and periodic submission of safety reports; provide support to global personnel regarding Global Patient Safety (GPS) procedures and processes; collaborate with internal and external parties to ensure safety reporting process is established. CIS includes: Belarus, Trans-Caucasian countries Armenia, Azerbaijan, Georgia, and CARM (Central Asia Republics and Mongolia): Kazakhstan (KZ), Kyrgyzstan, Tajikistan, Turkmenistan, Uzbekistan, and Mongolia. Primary Responsibilities: General

• Fulfil the legal and regulatory requirements for the QPPV responsible for pharmacovigilance role as defined by legislation and/or guidelines in Azerbaijan
• Ensure local Patient Safety Contacts are appointed for Azerbaijan as per the national requirement
• As necessary, ensure that any changes to the details of the Local QPPV are notified promptly to the MoH/RA
• Understand the role of the EU Qualified Person for Pharmacovigilance (QPPV) and assist as required.
• Responsible for the establishment and maintenance of Lilly’s local pharmacovigilance system, including the performance of the quality system and pharmacovigilance activities in order to promote, maintain and improve compliance with the legal requirements and relevant Good Vigilance Practice (GVP) requirements in the region.
• As necessary, ensure appropriate backup coverage is in place in times of absence or unavailability.
• Ensure consistency and compliance with all processes and procedures within Patient Safety
• Ensure appropriate interpretation and implementation of national pharmacovigilance legislation/regulation.
• Liaise with Patient safety employees to ensure a coordinated approach and consistent case management, expedited and periodic reporting standards
• Function as back-up for case management, periodic reporting, expedited reporting and for applicable safety operations across SAMETA countries
• Ensure the appropriate communication of safety issues with other internal functions and Global Patient Safety management
• Ensure completion of action items of GPS Quality Plan and Corrective and Preventive Action (CAPA) within the required timeline
• Ensure local business alliance and third-party safety agreements are in place, up to date and followed as required
• Understand the handling of confidential information (patient privacy, confidential audits, and regulatory inspections)
• Ensure approved AE/PC training material is provided to the Alliance partner(s) for AE/PC reporting requirements
• Train Business Alliance partners and/or Third-Party Vendors on reporting requirements, as required

Adverse Event (AE) Management Responsibilities

• Serve as point of contact for reception and collection of AE reports.
• 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 in collaboration with the relevant BPs and/or Third-Party Vendors.
• Responsible for generating and submission of the necessary case reports to BPs and/or Third-Party Vendors 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.

BP Oversight and Support

• Participate in Alliance (Pharmacovigilance related) Meetings.
• Serve as affiliate pharmacovigilance contact point for queries from BPs, 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.
• Maintaining the Periodic Safety Updated Reports (PSURs) submission tracking tool up to date for the related countries
• Collaborate in development and maintenance of local safety agreement with partners to ensure accuracy of safety language and requirements.

Minimum Qualification Requirements:

• Bachelor’s degree (or higher) in a health profession (i.e. Pharmacy, Medicine) or life science field or equivalent demonstrated experience is required
• 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
• Professional knowledge of English including medical terminology
• Effective communication skills to interact with diverse groups and individuals
• Basic computer skills

Other Information/Additional Preferences:

• Excellent communication (written and verbal), interpersonal, organizational and negotiation skills.
• Strong knowledge of quality systems

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) 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 ( ) 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.

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