Job title: PV & Medical Audit and Inspection Readiness Manager

Hiring Manager: Head of M&S Services, Hyderabad Hub

Location: Hyderabad

% of travel expected: Travel required as per business need

Job type: Permanent and Full time

About the job

Our Team:

Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions and consumer healthcare. More than 110,000 people in over 100 countries at Sanofi are dedicated to making a difference on patients’ daily life, wherever they live and enabling them to enjoy a healthier life.

As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with strong commitment to develop advanced data standards to increase reusability & interoperability and thus accelerate impact on global health.

The Global M&S Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global M&S teams in partnership with Business and Digital, and drive priority and transformative initiatives across M&S. The team members of Global M&S Services Hubs will act as partners in carrying out tasks and fulfilling responsibilities to support identified and established global quality processes from the hubs.

Main responsibilities:

Regulatory GxP Inspections

Coordinate and prepare for selected PV inspections at Global/Local level, other GxP inspections with PV involvement such as Good Clinical Practices (GCP) pre-authorization sponsor/site.

Inspections (PAI) and Good Manufacturing Practices (GMP) inspections across all GBUs/MAHs.

Manage inspection preparation, conduct and follow-up until closure.

Manage the completion of Health Authorities PV risk assessment questionnaires to support risk-based PV inspection planning in collaboration with appropriate SMEs.

GxP Audits

Coordinate and prepare for selected Global Quality Audits (GQA) impacting global PV and medical processes/tools and for business partner audits hosted by PSPV. For these audits, manage audit preparation, conduct and follow-up until closure.

Manage the completion of Business Partners PV risk assessment questionnaires to support their risk-based PV audit planning, in collaboration with appropriate SMEs.

Business Partners PV audits

Contribute to the preparation of Business Partners annual audit programs based on risk assessment results provided by PVA team and CSHs.

Oversee the preparation and execution of the related PV audits programs by external contractors and external auditors.

Ensure follow-up of CAPAs at Business Partner, including closure within the designated timelines and tracking of CAPAs evidences.

Assess audits findings, perform trending analysis and communicate areas of risk to PV / Medical GBUs / Quality management.

Ensure appropriate and timely data entry into Quality Management System of relevant audits findings and CAPA information.

Responsible for the maintenance of the appropriate quality documentation related to this activity.

Responsible for the preparation of related Business Partners audits sections / annexes for the maintenance of PSMF.

Global PV Service Providers audits

Support the preparation and execution of the Global PV service providers annual audit program as per defined processes.

Ensure the liaison between the outsourcing team internally, auditors who carries out the audits and Sanofi’s global PV service provider who will be audited throughout the pre-audit period, during the audit and post-audit.

Audits/Inspections Readiness

Maintain PV audit/inspection readiness at all times.

Perform QC of the PV System Master File (PSMF) during the regular revision cycle and of Local PSMF(s) in the context of Regulatory inspections.

Organize and archive all relevant documentation for audits/inspections in the shared repository and team generic mailbox.

Serve as the point of contact for all global audits and inspections activities related to PSPV as per assignment, including interfacing and communicating with regulatory authority representatives as required.

About you

Experience:

A minimum of 5 years of experience in Pharmacovigilance or clinical field, preferably in quality management activities.

A minimum of 7 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.

Education:  Bachelor’s or higher in Pharmacy or biological science discipline

Languages: Excellent knowledge of English language (spoken and written)

Why choose us?

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?

Pursue progress, discover extraordinary

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, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

Pursue progress, discover extraordinary

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 ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!