Audit and Inspection Coordinator - VIE Contract

Audit and Inspection Coordinator - VIE Contract 

• Location: Netherlands, Amsterdam
• Target start date: 01/03/2025

iMove, the Sanofi VIE Program, is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28. 

PLEASE NOTE that since this program is primarily an international development program, candidates cannot apply to a VIE assignment in their own country of citizenship. 

PLEASE NOTE that applications that are only submitted in French cannot be considered by our non-French speaking partners at Sanofi worldwide. Therefore, only applications that are submitted in English will be considered. Please make sure to apply with your personal email address.  

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. Your job, as Audit and Inspection Coordinator within our Medical and Pharmacovigilance (MPV) Quality team, will be to work with global teams to integrate quality standards and initiatives. You will be integrated in routine activities such as PV audit preparations and follow up, health authority PV inspections support, audit and inspection findings trending and oversight of CAPA implementation. All the projects include tools / digital initiatives and process improvements.

You will also engage in development and implementation of training materials related to process improvement initiatives and contribute in joint projects between Audit and inspection readiness team and PV compliance team.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible.

Ready to get started?

Main responsibilities:

• Support AIR (Audit and Inspection readiness) team activities for audits and inspections, i.e. support the management of pre-requests, participation in the back room, follow up of CAPAs, and other.
• Contribute to deliver metrics for the Quality Forum, AIPG Meeting (Audit/inspection PV Governance), PSPV quarterly reports (Patients Safety Pharmacovigilance) and monthly reports.
• Support the management of PV Service Providers and Business Partners audits.
• Support in the preparation of country office audits and inspections, definition of root-cause analysis and Corrective & Preventive Actions (CAPA) follow-up.
• Support country office to pull ICSR (Individual Case Safety Report) compliance data at time of audits and inspections and for routine monitoring, and work with PV Compliance team to identify missing investigations and / or trends related to local ICSR Compliance.
• Provide analysis of PV findings trends across regions for audits and inspections.
• Lead and support AIR apprentice in the launch of the survey for the lessons learned from the PV inspections and support the preparation of the action plan based on the results.

About you

Experience:

• Experience in Pharmacovigilance / Medical Affairs / Regulatory Affairs or Quality Assurance.
• Experience in CAPA (Corrective and Preventive Actions) management would be a plus.
  

Soft and technical skills:

• Understanding of Pharmacovigilance regulatory requirements.
• Knowledge of MS office (proficient use of Excel and PowerPoint).
• Tech-savvy – advanced knowledge of MS office (Excel and PowerPoint), PowerBI, SmartSheet or other tools.
• Good interpersonal communication and networking skills with ability to network with key stakeholders.
• Dependability, independent yet willing to incorporate feedback.
• Efficient at time management, organized, detail and goal oriented.
• Analytic thinker with effective problem-solving skills.

Education:

• Pharmaceutical Degree or Master's Degree in Human Health Sciences or similar.
  

Languages:

• Fluent in verbal and written English.

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