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.
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Croatia |Zagreb :
Zagreb |Estonia :
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