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    Quality & Compliance Team Lead – Remote

    Iqvia
    3-5 years
    Not Disclosed
    Remote, USA
    12 June 28, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, 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: Quality and Compliance Team Lead

    Company Overview:

    IQVIA is a global leader providing advanced analytics, technology solutions, and clinical research services to the life sciences industry. They focus on delivering accurate perspectives and in-depth analytics to empower healthcare decisions worldwide.

    Role Overview:

    As a Quality and Compliance Team Lead at IQVIA, you will play a pivotal role in ensuring adherence to the highest standards of quality and compliance within the organization. This position requires leadership in commercial patient services, pharmacovigilance, quality assurance, and regulatory compliance.

    Key Responsibilities:

    • Act as the primary quality and compliance leader for assigned client(s), ensuring alignment with Patient Support Services operational processes and business objectives.
    • Provide leadership in drug safety and pharmacovigilance, fostering a culture of collaboration, excellence, and continuous learning.
    • Oversee the daily collection, evaluation, and processing of safety data to ensure compliance with regulatory and client requirements, addressing discrepancies promptly and responding to client inquiries.
    • Maintain up-to-date knowledge of industry standards and client regulatory requirements, ensuring IQVIA’s compliance with pharmacovigilance regulations and guidelines.
    • Lead proactive identification of potential safety signals, collaborating with cross-functional teams to develop risk minimization strategies.
    • Prepare comprehensive reconciliation reports and quality/compliance reports aligned with client contractual obligations.
    • Coordinate training requirements to ensure team readiness, supporting training delivery as necessary.
    • Identify areas for process improvement in quality and compliance workflows, optimizing internal processes to enhance service offerings.
    • Serve as a subject matter expert during client audits/inspections, ensuring compliance and providing support in audit findings evaluation and corrective action planning.
    • Contribute to the development of Quality Assurance Standard Operating Procedures (SOPs) as assigned, leveraging deep expertise in the field.
    • Support maintenance of IQVIA’s electronic quality management system (eQMS), ensuring accuracy and providing crucial support throughout the audit lifecycle.

    Minimum Required Education & Experience:

    • Associates/Bachelor’s degree in pharmacy, life sciences, or related field; advanced degree preferred.
    • 3-5 years of experience in drug safety, pharmacovigilance, quality assurance, or related field.

    Skills and Abilities:

    • Excellent communication, interpersonal, and negotiation skills.
    • Analytical mindset with strong problem-solving abilities.
    • Detail-oriented with a commitment to maintaining high quality standards.
    • Ability to make informed decisions under pressure.
    • Proven leadership experience in a cross-functional environment.
    • Proficiency in data collection and quality management tools.
    • Familiarity with Microsoft Office applications; advanced skills in Excel, Word, and PowerPoint.
    • Experience with pharmacovigilance databases and adverse event reporting systems preferred.
    • Background in quality assurance within life sciences or pharmaceutical industry is advantageous.

    About IQVIA:

    IQVIA strives to push the boundaries of human science and data science to create a healthier world. They foster a culture of innovation and collaboration, where individual contributions make a significant impact.

    For more information, visit IQVIA Careers.

    Equal Opportunity Employer:

    IQVIA is committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. Learn more about their commitment at IQVIA Equal Employment Opportunity.

    COVID-19 Vaccination Policy:

    IQVIA requires employees to meet specific COVID-19 vaccination status requirements to operate and provide services to customers and partners. Learn more about their policy at IQVIA COVID-19 Vaccination Status.

    Compensation:

    The potential base pay range for this role is $55,000-$60,000 annually, with actual compensation varying based on qualifications, location, and schedule. Additional incentives, bonuses, and benefits may also be offered.

    This structured format emphasizes clarity and conciseness, highlighting key responsibilities, qualifications, company overview, and important policies related to the role at IQVIA.

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