Good Clinical Practices And Pharmacovigilance Sr. Auditor

2+ years

Not Disclosed

Mexico

10 Dec. 10, 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

Novartis Lead Auditor – GCP/PV, Mexico City, Mexico
Innovative Medicines, Quality

About Novartis
Novartis is dedicated to improving and extending lives worldwide through innovative science. We foster a culture of collaboration, empowerment, and inclusivity where passionate individuals work together to achieve breakthrough results in healthcare.

Role Overview
As a Lead Auditor, you will lead and support global GCP/PV audits to ensure compliance with regulatory standards, Novartis’ quality systems, and current regulations. You will play a key role in assessing risk, driving improvements, and providing expert guidance to Novartis business units on audit-related activities and corrective actions.

Key Responsibilities

Develop and support a global risk-based audit strategy, collecting input for the audit plan.
Lead, plan, and conduct global audits and assessments of GCP/GPvP in compliance with Novartis Quality Module, regulations, standards, and guidance.
Provide technical guidance and training to other auditors, ensuring they perform audit activities with high independence.
Document and prepare audit reports within set timelines and Novartis quality standards.
Escalate critical findings to management and ensure effective follow-up and corrective actions.
Evaluate and approve corrective action plans (CAPAs) in collaboration with relevant stakeholders.
Communicate quality and compliance issues, recommending solutions and improvements.
Support mock Pre-Approval Inspections (PAIs) and Health Authority inspections as required.
Mentor junior staff, sharing knowledge and expertise in GCP/PV audits.
Maintain knowledge of regulatory changes, industry trends, and best practices related to GCP/PV compliance.
Review and approve audit reports, ensuring they meet Novartis standards.

Key Performance Indicators

Effective execution of the Unified Quality Audit Plan (UQAP).
Timely completion of audits, delivering high-quality findings and reports within established timelines.
Effective escalation and communication of compliance issues impacting GCP/PV practices.
Successful collaboration with business partners to resolve non-compliance and improve quality.
Timely facilitation of HA inspections and audit follow-ups.
Contribution to global compliance and quality improvement initiatives.

Job Dimensions

Location: Mexico City, Mexico
Division: Operations
Business Unit: Innovative Medicines
Functional Area: Quality
Job Type: Full time, Regular
Shift Work: No

Why Novartis?
At Novartis, we are committed to transforming healthcare by working collaboratively to deliver life-changing therapies to patients. Join us in creating a brighter future together.

Commitment to Diversity & Inclusion
Novartis is an Equal Opportunity Employer committed to fostering an inclusive and diverse workforce. We welcome applicants from all backgrounds and are dedicated to maintaining an environment that empowers our people to achieve their full potential.

Join Our Novartis Network
Not the right role for you? Stay connected by joining our talent network and receive updates on future opportunities.

Benefits and Rewards
Explore how we support employees with a range of benefits that help you thrive personally and professionally. Learn more in our Benefits Handbook.

Accessibility and Accommodation
Novartis is committed to providing reasonable accommodations to individuals with disabilities during the recruitment process. If you need assistance, please email tas.mexico@novartis.com.

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Good Clinical Practices And Pharmacovigilance Sr. Auditor

Job Description

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