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    Global Pharmacovigilance Senior Associate And Capa System Business Owner

    Zoetis
    2+ years
    $61,000 - $87,000
    Remote, USA
    10 Nov. 5, 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, 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: Senior Associate, Global Pharmacovigilance (GPV) CAPA Management
    Location: Flexible (Remote Available)

    Job Summary

    As a Senior Associate within Global Pharmacovigilance (GPV) at Zoetis, you will play a key role in managing the Deviation/CAPA process, ensuring compliance with regulatory requirements and driving continuous improvement within the PV system. You will serve as a Subject Matter Expert for the CAPA database, overseeing the effective use of the system across the organization, and ensuring timely completion of CAPA deliverables. This role offers an opportunity to support GPV's broader mission, contributing to high-quality pharmacovigilance operations and global safety reporting.

    Key Responsibilities

    CAPA Management & Oversight

    • Lead GPV CAPA Process: Manage and oversee the Deviation/CAPA process to ensure compliance with regulatory requirements and Zoetis' internal standards.
    • CAPA System Optimization: Act as the CAPA database Subject Matter Expert (SME), ensuring that the system is used effectively within GPV and continuously optimized for best performance.
    • Documentation & Training: Ensure proper documentation of CAPA activities and provide training to GPV and other Zoetis staff as needed on the CAPA database and process.
    • CAPA Record Creation & Tracking: Create and manage CAPA records, monitor deliverables, and ensure timely completion of action items.
    • Follow-up and Facilitation: Follow up with CAPA owners and facilitate timely completion of CAPA action items.

    Regulatory & Cross-functional Support

    • Regulatory Inspections: Assist in agency-related matters such as the Pharmacovigilance System Master File (PSMF) and Agency Inspections related to GPV CAPA activities.
    • Cross-functional Collaboration: Partner with key internal stakeholders to ensure that investigations are thorough, comprehensive, and comply with all regulatory and internal requirements.

    Additional Responsibilities

    • Project Support: Contribute to the workload of the GPV team by taking on specific projects or additional responsibilities as needed, ensuring the team's success.
    • Continuous Improvement: Assist in improving GPV processes, making recommendations for enhancements and driving efficiency in pharmacovigilance operations.

    Qualifications

    Experience & Background

    • Relevant Experience: Proven experience in Global Pharmacovigilance or a regulated environment, with a demonstrated understanding of safety management systems and CAPA processes.
    • CAPA Systems Experience: Familiarity with Mastercontrol or other CAPA management systems is desirable but not essential.

    Technical Skills

    • Administrative Support: Demonstrated ability to provide administrative support in a dynamic, multicultural environment.
    • Microsoft Office Expertise: Proficiency in Microsoft Word and Excel, with a high level of competency in using these tools for data analysis and reporting.
    • Effective Communication: Strong verbal and written English communication skills, capable of interacting with colleagues at all levels of the organization and external regulatory agencies.
    • Problem-Solving Skills: Strong interpersonal and problem-solving abilities, with a focus on delivering creative solutions and taking ownership of issues.
    • Team Collaboration: Ability to work effectively as part of a team, influence others without authority, and handle multiple tasks efficiently.

    Desirable

    • Experience with Pharmacovigilance Audits and Regulatory Inspections
    • Zoetis' Global Pharmacovigilance Database Knowledge
    • Experience in CAPA Process Documentation
    • Familiarity with Business Objects Reports

    Compensation & Benefits

    Base Pay Range

    • Colorado: $61,000 - $87,000
    • California, NJ, NY, Washington (Remote): $69,000 - $99,000

    In addition to competitive pay, this position is eligible for short-term incentive compensation and a comprehensive benefits package, which includes healthcare, dental coverage, retirement savings benefits, paid holidays, vacation, and disability insurance.

    Zoetis Equal Opportunity Statement

    Zoetis is an Equal Opportunity Employer. We prohibit discrimination and harassment of any kind, regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, or veteran status. We offer reasonable accommodations for individuals with disabilities and are committed to ensuring a diverse and inclusive workplace for all employees.

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