Pv & Medical Audit And Inspection Readiness Manager

Sanofi

7+ years

Not Disclosed

Hyderabad

10 Oct. 17, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: PV & Medical Audit and Inspection Readiness Manager

Hiring Manager: Head of M&S Services, Hyderabad Hub
Location: Hyderabad
% of Travel Expected: As required by business needs
Job Type: Permanent and Full-time

About the Job

Our Team:

Sanofi is a global life sciences company dedicated to enhancing healthcare access and supporting the individuals we serve throughout their health journeys. From prevention to treatment, we transform scientific innovation into healthcare solutions across various areas, including human vaccines, rare diseases, oncology, immunology, diabetes, and consumer healthcare. With over 110,000 employees in more than 100 countries, Sanofi is committed to making a difference in patients' lives, empowering them to lead healthier lives.

Recognized as one of the top pharmaceutical companies, Sanofi is pioneering the application of Artificial Intelligence (AI) to enhance drug development and improve data standards, ensuring greater reusability and interoperability in global health.

The Global M&S Services team is integral to this vision, responsible for supporting Global M&S teams and driving transformative initiatives across the organization.

Main Responsibilities

Regulatory GxP Inspections:

Coordinate and prepare for pharmacovigilance (PV) inspections at both global and local levels, including Good Clinical Practices (GCP) and Good Manufacturing Practices (GMP) inspections.
Manage all phases of inspection preparation, execution, and follow-up until resolution.
Collaborate with subject matter experts (SMEs) to complete Health Authorities PV risk assessment questionnaires for effective inspection planning.

GxP Audits:

Coordinate and prepare for Global Quality Audits (GQA) affecting global PV and medical processes.
Manage the audit process from preparation to closure, ensuring completion of risk assessment questionnaires with appropriate SMEs.
Oversee the execution of PV audits conducted by external contractors and ensure timely follow-up on corrective and preventive actions (CAPAs).

Global PV Service Providers Audits:

Support the preparation and execution of the annual audit program for Global PV service providers.
Act as the liaison between the internal outsourcing team, auditors, and Sanofi’s global PV service providers during audits.

Audit/Inspection Readiness:

Maintain ongoing PV audit and inspection readiness.
Perform quality control of the PV System Master File (PSMF) and organize all relevant documentation for audits and inspections.

Point of Contact:

Serve as the primary contact for global audit and inspection activities related to PV, interfacing with regulatory authority representatives as necessary.

About You

Experience:

Minimum of 5 years in Pharmacovigilance or a clinical field, with a focus on quality management.
At least 7 years in the global pharmaceutical industry, encompassing both post-marketing and clinical development activities.
Proven experience working in diverse cultural environments.

Education:

Bachelor’s degree or higher in Pharmacy or a related biological science discipline.

Languages:

Excellent proficiency in English (spoken and written).

Why Choose Us?

Join us in our mission to chase the miracles of science and improve lives. At Sanofi, you’ll have the opportunity to flourish in your career, explore new challenges, and connect with inspiring colleagues.

Pursue Progress. Discover Extraordinary.

Better outcomes, better medications, better science – that’s what we strive for. But achieving this progress requires passionate individuals from diverse backgrounds, united in the goal to make a difference. Become one of those people with us.

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

Watch our ALL IN video to learn more about our Diversity, Equity, and Inclusion initiatives!

Let’s pursue progress together and discover the extraordinary potential that lies within each of us.

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Pv & Medical Audit And Inspection Readiness Manager

Job Description

Job Title: PV & Medical Audit and Inspection Readiness Manager

About the Job

Main Responsibilities

About You

Why Choose Us?

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