Medical and PV Audit and Inspection Readiness Professional

About the job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

Join our Audit and Inspection Readiness (AIR) team and be part of the Medical and PV quality (MPVQ) team reporting to Global Quality Medical, Clinical & Country Quality Operations (MCCQ) within Global Quality department.

AIR team mission is to ensure that the organizations in scope are inspection-ready and to support preparation, conduct and follow-up of inspections and audits requiring Medical and PV input.

Main responsibilities :

Responsibilities cover PV and Medical related activities across all Business Units, working directly with GBU Medical, Pharmacovigilance, Regulatory, and Clinical and across the local Sanofi commercial offices (all Sanofi legal entities), as well as with Country Quality teams and other Global Quality GxP operational units, as required.

The Audit and Inspection Readiness Prefessional is responsible to ensure :

• Support of the ongoing permanent inspection preparedness and readiness of Global Pharmacovigilance (Patient Safety Pharmacovigilance-PSPV) and country PV offices in anticipation of regulatory inspections and audits
• Support the preparation, conduct and follow-up of GxP regulatory inspections impacting PV 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 processes / tools or Business Partner audits, until closure
• The follow-up of audit / inspections PV-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
• The management of Business Partners and Global Service Providers PV Audits activity, in collaboration with external auditors and related PSPV functions

About you

Experience :

• A minimum of 3 years of experience in Pharmacovigilance or clinical field, preferably in quality management activities
• 5+ years of experience in global pharmaceutical industry, including experience in both post-marketing and clinical development activities
• Experience working in a global environment, across diverse cultures
• Excellent knowledge of International (ICH / CIOMS), EU (Good PV practices) and FDA regulations in the domain of Pharmacovigilance
• Familiarity with Quality systems

Soft skills :

• Ability to take initiative and to overcome challenges, capability to work under pressure
• Ability to work in transversal / cross functional teams with excellent teamwork and interpersonal skills
• Advanced Negotiation and Influential skills
• Excellent communicational skills
• Advanced in project management

Technical skills :

• Quality risk analysis and quality Risk Management
• Advanced with Microsoft Office Suite

Education : Min. Bachelor’s degree in Life Sciences

Languages : Full professional English language proficiency (both written and oral)

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team in an international work environment
• Work from an "Office of the Year 2023" award winner with flexible home office policy
• 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
• An individual and well-structured introduction and training of new employees and we will dedicate a Buddy for you to better navigate in your first weeks
• Join a great community & special events (Monthly Board Game Nights, Summer Events, Well-Being Lectures & Sport Clubs)

Pursue . Discover .

Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing : a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our and check out our Diversity Equity and Inclusion actions at !

Discover our , that serves as the moral compass that guides us when chasing the miracles of science to improve people’s lives. Please ensure to have read this document before applying.

Sanofi #SanofiCareers #joinSanofi

jobopportunities #careeropportunities #sscjob

Sanofi_Budapest_Hub #Budapest

LI-EUR #LI-hybrid

Pursue , discover

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing : a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our and check out our Diversity Equity and Inclusion actions at !