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 Medical Information and Pharmacovigilance Associate role is to provide medical information about company products to external customers via answering unsolicited requests and collaborate on daily pharmacovigilance (PhV) activities to ensure compliance with internal and external requirements.

Person works closely with Medical Information and Pharmacovigilance Manager / local Primary PhV person and serves as PhV Back-Up during an absence of the primary PhV person.

Primary Responsibilities:

Medical Information (Medinfo) Enquiries Management

Handling calls and written requests for product related medical information from healthcare professionals (HCPs) and public.Providing written balanced, scientifically based, consistent and accurate medical information responses to unsolicited medical questions from HCPs using pre-prepared available content.Accurate recording of all medical communication transactions into the medical information database in accordance with Good Documentation Practices.Collaborate with affiliate and  Czech cluster MedInfo team.Escalate all enquiries without predefined answers to a more specialized teamEnsure optimal customer satisfaction.

Create, Promote and Maintain Operational Excellence

Maintain and enhance Lilly product and disease knowledge.Participate in internal and external educational opportunities relevant to the Medical InformationCollaborate effectively with brand team and medical affairs.

Pharmacovigilance

Perform required PhV activities in collaboration with Pharmacovigilance Manager/primary local PhV person, during absence of primary local PhV person  serve as PhV back up.

General Responsibilities and Regulatory Compliance:

Execution of pharmacovigilance activities as nationally required (e.g. adverse event management, expedited and periodic reporting, maintenance of the Pharmacovigilance System Master File (PSMF).Understand the role of European Union Qualified Person for Pharmacovigilance (EU QPPV).Responsible for appropriate communications between product safety locally, Global Patient Safety, and other relevant stakeholders (product complaints, medical and regulatory affairs).Monitor national pharmacovigilance legislation.Escalate safety and compliance issues to PhV manager and Medicines Quality representative.Communicate with regulatory authority, work with legal, quality, medical and regulatory on safety issues if required during the absence of the primary PhV person.Collaborate on updating and verification of the information contained in Lilly’s PSMF and associated country documents to ensure that they are maintained as applicable.Collaborate on providing local training (initial and/or refresher) for employees and/or Business Alliance partners

Submission of pharmacovigilance documents and reports to the local regulatory authorities Adverse event management responsibilities:

Serve as point of contact for collection of Adverse Event (AE) reports.Adverse event/ device case entry into the safety database as applicable.Complete case follow-up as directed or required.Reconciliation of case reports with business partnersProcess outputs from PhV literature screening of local medical journals received from vendor.Filing and archiving pharmacovigilance documents.

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, leading and providing clarification on local implementation where applicable.Help to interpret relevant regulations and guidelines and acts as a contact person in the affiliate.Responsible for ensuring compliance with regulatory authority requirements and GPS policies, procedures and processes.

Minimum Qualification Requirements:

Education: University Degree in medicine, healthcare, natural sciences, pharmacy, or equivalent including experience in related disciplines.Professional knowledge of English including medical terminology.High-level end-user computer skills including working with various databases.

Other Information/Additional Preferences:

Medical background or experience in pharmacovigilance area.Good organizational and time management skillAbility to effectively prioritize and handling multiple tasks.Focus on details, accuracy and keeping timelines.Effective communication skills to interact with diverse groups and individuals.

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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