Manager Cpvqa (Remote)

5+ years

Not Disclosed

Remote

10 Dec. 30, 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

Manager, CPVQA (Remote)
Req ID: R009950
Location: Dublin, IE [Remote/Home-Based]
Category: Technical Operations

About Jazz Pharmaceuticals
Jazz Pharmaceuticals (NASDAQ: JAZZ) is a global biopharmaceutical company dedicated to transforming the lives of patients and their families. We specialize in developing life-changing medicines for serious diseases with limited or no therapeutic options. Our diverse portfolio includes both marketed medicines and novel product candidates across neuroscience and oncology. We innovate through novel compounds, small molecules, biologics, and cannabinoid science. Headquartered in Dublin, Ireland, Jazz serves patients in nearly 75 countries worldwide.

Position Overview
The Manager, Clinical and Pharmacovigilance Quality Assurance (CPVQA) will play a key role in ensuring Jazz’s pharmacovigilance (PV) system complies with applicable regulations, industry standards, Jazz policies, and quality guidelines. This individual will support global quality and R&D leaders in providing strategic input and tactical implementation for pharmacovigilance system activities and projects. The role will involve overseeing audits, managing vendor relationships, and driving inspection readiness, ensuring compliance with internal and external standards.

Essential Functions/Responsibilities

Develop expertise in local and international pharmacovigilance regulations and quality requirements.
Contribute to executing the global pharmacovigilance audit strategy, ensuring compliance within the Quality Management System.
Review internal and external Standard Operating Procedures (SOPs) and participate in the development of new SOPs for quality and PV system stakeholders.
Assist in updating quality-related sections in the Pharmacovigilance System Master File (PSMF) and similar documents.
Conduct risk assessments for pharmacovigilance system audits.
Implement strategic audit plans for PV system activities, covering service providers, vendors, business partners, and internal audits.
Participate as an auditor/co-auditor in internal and external audits, managing vendor relationships as needed.
Present audit findings and observations to internal teams, service providers, and partners.
Contribute to evaluating Corrective and Preventative Actions (CAPAs) and ensure timely closure of audit findings.
Support inspection readiness activities and inspections, performing roles such as inspection readiness training, scribe, or SME preparation.
Identify critical quality issues and escalate them to senior management as necessary.
Contribute to continuous quality process improvements and root cause investigations.
Represent CPVQA in interdepartmental teams and innovation projects.
Maintain up-to-date training as per the curriculum.

Required Knowledge, Skills, and Abilities

Strong knowledge of Good Pharmacovigilance Practices (GVP) and experience in quality assurance.
Excellent written and verbal communication skills.
Ability to thrive in an entrepreneurial and fast-paced environment.
Experience in GVP auditing is preferred; GVP lead auditor certification is desirable.
Strong self-direction with the ability to take action when necessary.
Collaboration skills to work with internal and external partners.
Detail-oriented with strong time management skills.
Knowledge of post-authorization commitment requirements (Phase IV, PASS Studies) and Managed Access Programs is a plus.
Experience with GCP, GLP, and GDP is an advantage.
Inspection experience with FDA, MHRA, or other regulatory authorities is desirable, with additional knowledge of emerging markets such as PMDA being a plus.

Education and Licenses

Bachelor’s degree in a related field required. Master’s degree in management, leadership, or scientific discipline preferred.

Equal Opportunity Employer
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, veteran status, or any characteristic protected by law.

Compensation and Benefits
The successful candidate will be eligible for Jazz’s benefits package, which includes medical, dental, vision insurance, a retirement savings plan, and flexible paid vacation. For more information on our benefits offerings, please click here.

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Manager Cpvqa (Remote)

Job Description

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