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    Pharmacovigilance Lead

    Eli Lily
    2+ years
    Not Disclosed
    Istanbul
    10 Jan. 30, 2025
    Job Description
    Job Type: Full Time Education: B.Sc, M.Sc, B.Pharm, M.Pharm, LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Pharmacovigilance Lead
    Location: Istanbul, Türkiye
    Category: Research & Development
    Job Type: Full-Time Regular
    Job Id: R-77916

    About Lilly:

    At Eli Lilly, we unite caring with discovery to make life better for people around the world. As a global healthcare leader headquartered in Indianapolis, Indiana, our employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of diseases, and give back to our communities through philanthropy and volunteerism. We're looking for determined individuals who want to help us make life better for people worldwide.

    Position Summary:

    The Pharmacovigilance Lead will be responsible for ensuring compliance with pharmacovigilance regulations and overseeing the implementation of pharmacovigilance activities in alignment with local, regional, and global guidelines. This role plays a key part in ensuring the safety of patients and the compliance of drug products, while managing a team of professionals within the local affiliate.

    Key Responsibilities:

    Regulatory Compliance & System Management:

    • Ensure compliance with legal and regulatory requirements for pharmacovigilance in the respective region, including adherence to Good Vigilance Practice (GVP).
    • Establish and maintain the local pharmacovigilance system, ensuring adherence to quality systems and activities that promote compliance with legal requirements.
    • Understand and manage pharmacovigilance activities such as adverse event management, expedited and periodic reporting, risk management, and maintenance of the Pharmacovigilance System Master File (PSMF).
    • Act as a liaison between Global Patient Safety (GPS) and the local affiliate, ensuring appropriate communication of safety issues.
    • Monitor safety and compliance metrics, implementing corrective and preventive actions where necessary.

    Training & Communication:

    • Lead training efforts on adverse event reporting for the local affiliate.
    • Serve as the point of contact for adverse event case entry and follow-up, ensuring that all relevant information is captured and forwarded to GPS within designated timeframes.
    • Ensure that the information in the European Pharmacovigilance System Master File (EU PSMF) is maintained and updated as necessary.

    People Management:

    • Recruit, train, and develop a team of professionals with a high standard of performance.
    • Implement performance management processes, including career development and succession planning, to maximize team potential and achieve company objectives.

    Inspection Readiness & Standards:

    • Ensure the affiliate is prepared for inspections, audits, and assessments related to pharmacovigilance.
    • Develop and provide clarification on safety-related standard operating procedures (SOPs) to ensure alignment with local laws and regulations.
    • Support the development of global SOPs and ensure compliance with regulatory authority requirements and GPS policies.

    Qualifications:

    Minimum Qualifications:

    • Bachelor’s degree in a health profession (Pharmacy or Physician).
    • At least 2 years of experience in drug safety or pharmacovigilance.
    • Knowledge and understanding of local, regional, and global pharmacovigilance procedures and guidelines.
    • Strong communication skills (both written and verbal) in English, including medical terminology.
    • Demonstrated knowledge of pharmacovigilance legislation and regulations.
    • Strong organizational and negotiation skills.
    • Knowledge of quality systems.

    Additional Preferences:

    • Experience in leading a pharmacovigilance team or managing safety systems for drug safety.

    Additional Information:

    Eli Lilly is committed to diversity, equity, and inclusion (DEI). We ensure an inclusive work environment where all employees are respected and given opportunities to excel. We also actively engage in promoting disability awareness through initiatives like our Access Lilly program, aimed at improving physical and digital accessibility for employees.

    Eli Lilly is an Equal Opportunity Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.

    How to Apply:

    If you're ready to make a meaningful difference with Lilly and meet the above qualifications, we invite you to apply for the Pharmacovigilance Lead position today!

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