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Audit And Inspection Coordinator - Vie Contract

2+ years
Not Disclosed
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

Job Title: Audit and Inspection Coordinator - VIE Contract
Location: Amsterdam, Netherlands
Target Start Date: 01/03/2025
Program: Sanofi iMove Program
Contract Type: VIE (International Volunteering for International Experience)

About the Job:
At Sanofi, we deliver 4.3 billion healthcare solutions annually, thanks to the dedication and precision of our Manufacturing & Supply teams. As an Audit and Inspection Coordinator within the Medical and Pharmacovigilance (MPV) Quality team, you will work with global teams to ensure compliance with quality standards and initiatives. You will engage in PV audit preparations, health authority PV inspections support, CAPA implementation, and process improvement projects. Your role will also involve contributing to the development of training materials and collaborating with multiple teams for joint projects.

This position offers an exciting opportunity to grow your career within a global healthcare leader, dedicated to improving lives and providing the space for your professional development.

Main Responsibilities:

  • Audit and Inspection Support: Assist the Audit and Inspection Readiness (AIR) team in managing audit and inspection preparations, including pre-requisite management, CAPA follow-up, and participation in backroom activities.
  • Reporting and Metrics: Contribute to metrics generation for the Quality Forum, AIPG Meeting, PSPV quarterly reports, and monthly reports.
  • Audit Support: Manage and assist with audits for PV service providers and business partners, as well as country office audits and inspections.
  • Compliance Data Management: Support the country office in pulling Individual Case Safety Report (ICSR) compliance data during audits, ensuring routine monitoring and assisting with the identification of trends.
  • Trend Analysis: Analyze PV audit and inspection findings across regions, contributing to identifying improvement opportunities.
  • Survey and Action Plan: Lead the launch of the survey for lessons learned from PV inspections and support the preparation of action plans based on results.

About You:

  • Experience: Previous experience in Pharmacovigilance, Medical Affairs, Regulatory Affairs, or Quality Assurance. Experience in CAPA (Corrective and Preventive Actions) management is a plus.
  • Skills:
    • Strong understanding of Pharmacovigilance regulatory requirements.
    • Proficient in MS Office, with advanced knowledge of Excel, PowerPoint, PowerBI, or SmartSheet.
    • Strong interpersonal and networking skills, with the ability to collaborate effectively with stakeholders.
    • Dependable, detail-oriented, and efficient at time management.
    • Analytical thinker with strong problem-solving skills.
  • Education: Pharmaceutical Degree or Master’s Degree in Human Health Sciences or related field.
  • Languages: Fluent in English (verbal and written).

Why Choose Us?
Sanofi’s iMove program offers a unique opportunity for European youth aged 18-28 to take on meaningful assignments in various global functions such as marketing, finance, regulatory, clinical trials, and more. As part of the iMove program, you will gain actual responsibilities and have the opportunity to grow professionally within a globally recognized healthcare company.

Joining Sanofi means being part of a diverse and inclusive team working together to chase the miracles of science and improve the lives of patients across the world.