Medical and PV Audit and Inspection Readiness Professional

Medical and PV Audit and Inspection Readiness Professional

Sanofi

Budapest, Hungary

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).

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