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Global Pharmacovigilance Senior Associate And Capa System Business Owner

5+ years
Not Disclosed
10 Oct. 22, 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

Senior Associate, Global Pharmacovigilance CAPA Management

Location: Remote
Employment Type: Full-Time

Role Overview

The Senior Associate will primarily manage the Global Pharmacovigilance (GPV) Corrective and Preventive Action (CAPA) process and support the overall operations of the GPV group.

Main Responsibilities

  • CAPA Oversight: Manage the Deviation/CAPA process for GPV and ensure objectives related to the GPV CAPA system are met.

  • Subject Matter Expertise: Act as the CAPA database expert, optimizing its use within GPV.

  • Documentation and Training: Provide adequate documentation and training on the CAPA database and Deviation/CAPA management for GPV and other Zoetis staff.

  • Action Item Management: Create CAPA records and ensure timely completion of action items.

  • Monitoring Deliverables: Track CAPA deliverables and facilitate completion through follow-ups with CAPA owners.

  • Agency Support: Assist with agency-related topics, including PSMF and inspections related to GPV CAPAs.

  • Cross-Functional Collaboration: Partner with stakeholders to ensure thorough investigations.

Additional Responsibilities

  • Contribute to the GPV group's workload by taking on specific projects as needed.

Experience and Background

  • Relevant experience in Global Pharmacovigilance or a regulated environment is essential.

  • Experience with MasterControl or other CAPA management systems is a plus but not mandatory.

Technical Skills Requirements

  • Administrative Support: Strong administrative skills in a multicultural and dynamic environment.

  • Microsoft Office: Proficient in Microsoft Word and Excel.

  • Communication: Excellent English communication skills for interactions with colleagues and regulatory agencies.

  • Interpersonal Skills: Model accountability and ownership; strong negotiation and problem-solving abilities.

  • Independence: Ability to work independently while fostering good relationships across distances.

  • Detail-Oriented: Critical attention to detail to meet submission expectations.

  • Team Player: Proven ability to collaborate effectively, take ownership of issues, and implement creative solutions.

  • Influence: Capability to influence without authority and support colleagues outside of GPV as needed.

Desirable Skills

  • Experience with pharmacovigilance audits and regulatory inspections.

  • Familiarity with Zoetis' Global Pharmacovigilance Database.

  • Experience documenting deviations and managing CAPA processes.

  • Interaction experience with Zoetis Regulatory Managers globally.

  • Ability to conduct Business Objects reports.

Salary Information

  • Base Pay Range (Colorado): $61,000 - $87,000

  • Base Pay Range (California, NJ Remote, NY Remote, Washington): $69,000 - $99,000

  • This position is eligible for short-term incentive compensation.

Benefits

Zoetis offers a competitive and comprehensive benefits package, including healthcare, dental coverage, retirement savings, paid holidays, vacation, and disability insurance.

Equal Opportunity Employment

Zoetis is committed to equal opportunity in employment without discrimination based on race, color, religion, sex, sexual orientation, age, gender identity, national origin, disability, veteran status, or any other protected classification. Reasonable accommodations are available for individuals with disabilities.