Global Pharmacovigilance Senior Associate And Capa System Business Owner

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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Global Pharmacovigilance Senior Associate And Capa System Business Owner

Job Description

Job Summary

Key Responsibilities

CAPA Management & Oversight

Regulatory & Cross-functional Support

Additional Responsibilities

Qualifications

Experience & Background

Technical Skills

Desirable

Compensation & Benefits

Zoetis Equal Opportunity Statement

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