Audit and Inspection Readiness Specialist - VIE Contract (W/M)

Job description

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.

We are looking for a candidate for a VIE mission of:

Audit and Inspection Readiness Specialist - VIE Contract (W/M)

Responsibilities:

The mission is to ensure that MAHs (Marketing Authorization Holders)/Sponsors audit and/or inspection readiness comply with the business partner agreement and/or regulatory obligations, specific to pharmacovigilance (PV). To support preparation, conduct and follow-up of business partner, internal and/or regulatory inspections impacting PV until closure.

The VIE is responsible to ensure:

·  Active involvement in the organization of appropriate support for the preparation, conduct and follow-up of Global Quality audits or Business Partner audits impacting global PV processes, until closure
·  Ensure completion of audit/inspections Pharmacovigilance related Corrective and Preventive Actions (CAPAs) to ensure timely completion and effectiveness to prevent recurrence
·  Participating in the ongoing permanent inspection preparedness and readiness of Global Pharmacovigilance and country PV offices in anticipation of Regulatory inspections and audits
·  Active involvement in the preparation, conduct and follow-up of regulatory inspections impacting PV until closure
·  Support external relations with Inspectorates / Agencies / Pharma associations to ensure surveillance of PV regulations in the field of PV inspections and benchmark on recurrent PV findings
·  Development of a standard pharmacovigilance database extract template to be used for audit and inspection

Requirements:

Education:

·  Master's degree in Pharmacy, Nursing or biological science discipline such as Biology, Health Sciences or other relevant field

Experience:

·  A minimum of 1 year of full time working experience in a similar position
·  Previous experience in pharmacovigilance, clinical inspections or regulatory affairs would be preferred

It skills:

·  Proficiency with MS Office suite

Language:

·  Fluent English

Other desirable skills:

·  Excellent knowledge of International, EU (Good PV practices) and FDA (Food and Drug Administration) regulations in the domain of Pharmacovigilance
·  Capability to work under extreme pressure
·  Excellent communication skills (oral and written)
·  Excellent organizational and planning capabilities
·  Ability to work in transversal/cross functional teams
·  Excellent teamwork and interpersonal skills
·  Ability to take initiative and to overcome challenges
·  Ability to interact with inspectorates from Health Authorities in a constructive manner

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.