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    Pharmacovigilance Coordinator

    Teva Pharmaceuticals
    5+ years
    Not Disclosed
    Ciudad de México
    10 Nov. 30, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc. 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 Coordinator

    Location: Ciudad De Mexico, Mexico
    Company: Teva Pharmaceuticals
    Job ID: 59480
    Date: Nov 26, 2024

    About Teva Pharmaceuticals

    Teva’s mission is to make good health more affordable and accessible to millions globally, enabling healthier lives. As the leading global manufacturer of generic medicines, Teva produces many essential medicines included on the World Health Organization’s Essential Medicines List. With 200 million people relying on Teva products every day, we are always seeking ways to improve and expand our impact. Join us in this meaningful mission.

    The Opportunity

    As a Pharmacovigilance Coordinator, you will be a vital member of the safety team, responsible for overseeing pharmacovigilance activities within the North America PV unit. You will collaborate with the Drug Safety Specialists, Pharmacovigilance Safety Specialists, and the Pharmacovigilance Managers/Directors to handle and review adverse event information for both pre- and post-marketing products.

    Key Responsibilities

    • Regulatory Compliance: Ensure that pharmacovigilance activities meet requirements of Health Authorities (e.g., FDA/Health Canada) and other global regulatory standards.
    • Team Management & Training: Provide guidance, training, and career development support to team members. Conduct performance appraisals and ensure all employees are equipped with necessary tools and training.
    • Adverse Event Management: Oversee the intake, extraction, and upload of adverse event data, including XML submissions, and ensure proper case registration.
    • Reporting & Follow-up: Coordinate with license partners and follow up with healthcare professionals or consumers to gather additional information as necessary. Ensure timely adverse event reporting to regulatory authorities.
    • Audit Participation: Participate in pharmacovigilance audits and inspections and provide necessary documentation for compliance.
    • CAPA Management: Draft and finalize Corrective and Preventive Actions (CAPAs) for non-compliance or late submissions.
    • SOP/WI Updates: Assist with the revision and updating of Standard Operating Procedures (SOPs) and Work Instructions (WIs) to ensure compliance with new regulations or improvements in processes.
    • Reconciliation: Perform daily, weekly, or monthly reconciliations of adverse event reports with identified partners and programs.
    • Documentation: Draft pharmacovigilance meeting agendas, minutes, and accurately archive documents.

    Qualifications & Experience

    • Education: Bachelor’s degree in Physics, Chemistry, Biology, Biochemistry, Microbiology, Physiology, Anatomy, Pharmacology, or related field.
    • Experience:
      • Over 5 years of global pharmaceutical industry or CRO experience, with at least 3 years in pharmacovigilance.
      • At least 2 years of experience in coordinating personnel and managing teams.
      • Proficiency with Microsoft Office (Word, Excel, PowerPoint, Adobe Acrobat).
      • Familiarity with pharmacovigilance IT systems such as Arisg, Argus, Cognos is a plus.
    • Skills:
      • Managerial & Leadership: Ability to manage and guide personnel effectively.
      • Teamwork & Communication: Strong communication, teamwork, and interpersonal skills to develop cooperative relationships across teams.
      • Analytical Thinking: Ability to analyze and implement plans to meet goals and objectives.
      • Training & Mentoring: Capable of training new hires and providing career development support.

    Why Teva?

    • Global Impact: Join a company making a difference in the lives of 200 million people every day.
    • Professional Growth: Develop your career in a global company with extensive training and career development opportunities.
    • Inclusive Culture: Teva fosters a diverse, inclusive, and supportive environment where you can contribute your best work.

    Teva Pharmaceuticals is an Equal Opportunity Employer, committed to diversity and inclusion. If you require accommodations during the recruitment process, please let us know, and we will ensure an accessible experience.

    #LI-Hybrid

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