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Pharmacovigilance Audit and Inspection Readiness Manager

AT Sanofi U.S.
Sanofi U.S.

Pharmacovigilance Audit and Inspection Readiness Manager

•Gunnison, CO

Job title: Pharmacovigilance Audit and Inspection Readiness Manager

Location: Bridgewater, NJ

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Main Responsibilities:

Reporting to the Medical/PV Audit and Inspection Readiness Head, the PV Audit and Inspection Readiness (AIR) Manager is responsible to ensure:

  • Participation in the ongoing permanent inspection preparedness and readiness of Global Pharmacovigilance (Patient Safety Pharmacovigilance-PSPV)PSPV), Medical GBUs and country PV offices in anticipation of regulatory inspections and audits.

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  • Active involvement in the preparation, conduct and follow-up of GxP regulatory inspections impacting PV/Medical until closure.
  • Active involvement in the organization of appropriate support for the preparation, conduct and follow-up of Global Quality audits impacting country GxP activities, global PV and Medical processes/tools, Global PV vendors or Business Partner PV audits, until closure.
  • Follow-up of audit/inspections PV/Medical-related Corrective and Preventive Actions (CAPAs) to ensure timely completion and coordination of CAPA effectiveness reviews in collaboration with CAPA owners, as needed to prevent recurrence.
  • Management of Business Partners PV Audits activity, in collaboration with external auditors and related PSPV.
  • Support in external relations with Inspectorates / Agencies / Pharma associations / Inter-Company network to ensure surveillance of PV inspections regulations/practices and benchmark on recurrent PV findings.
  • Support completion of Health Authorities and Business partners pharmacovigilance risk assessment questionnaires to facilitate risk-based PV inspection planning

    • About you:
    • Bachelor's degree Pharmacy (BS, RPh, Pharm D) or nursing (BSN, BScN) or biological science discipline. Advanced degree preferred.
    • 7+ years of experience in global pharmaceutical industry, including experience in both post-marketing and clinical development activities.
    • 5+ years of experience in Pharmacovigilance or clinical field, preferably in quality management activities.
    • Experience working in a global environment, across diverse cultures.

    Soft Skill & Technical Skills: Strong communication, problem solving, and leadership skills

    Languages: English required, Spanish a plus

    Why choose us?
    • This role provides the opportunity to work at the forefront of digital innovation in the pharmaceutical industry.
    • Bring the miracles of science to life alongside a supportive, future-focused team.
    • Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
    • Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
    • Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.

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    Client-provided location(s): United States
    Job ID: Sanofi-https://jobs.sanofi.com/en/job/bridgewater/pharmacovigilance-audit-and-inspection-readiness-manager/2649/17607533376
    Employment Type: Other

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