About Sanofi
Sanofi, a global healthcare company, has shown strong performance and strategic advancements in 2024. In the first quarter of 2024, Sanofi reported a 7% sales growth, with significant contributions from its key products. Dupixent sales increased by nearly 25%, reaching €2.8 billion, while new pharmaceutical launches, including Nexviazyme and ALTUVIIIO, saw a remarkable 90.5% growth (Sanofi) (Sanofi).
Sanofi continues to invest heavily in research and development (R&D), reflecting its commitment to innovation. The company has advanced several new drugs through its pipeline, achieving regulatory approvals and positive phase 3 results for various treatments. This includes three new Dupixent indications and Beyfortus in Japan (Sanofi).
Additionally, Sanofi announced the acquisition of Inhibrx, Inc., which brings INBRX-101, a promising treatment for Alpha-1 Antitrypsin Deficiency, into its portfolio. This move aligns with Sanofi’s strategy to strengthen its rare disease and immunology segments (Sanofi).
Sanofi also outlined plans to separate its Consumer Healthcare (CHC) business to focus more on innovative medicines and vaccines. This separation is intended to enhance the growth potential and strategic focus of both entities (Sanofi).
Expert Quality Services (Product Complaints)
Job Description
The Global M&S Services team is pivotal in ensuring the success of our organization. Our mission is to deliver top-tier support to Global M&S teams in collaboration with Business and Digital sectors, driving key transformative initiatives across M&S. Team members within the Global M&S Services Hubs play a crucial role as partners, executing tasks and responsibilities to support and uphold global quality processes.
Main Responsibilities
- Handling Complaints: Manage Product Technical Complaints and Field Alerts for medical devices, pharmaceuticals, biologics, and combination products, ensuring adherence to regulatory standards.
- Process Management: Oversee the entire lifecycle of Product Technical Complaints and Field Alerts from receipt to closure, complying with internal procedures and regulatory requirements.
- Collaboration: Work closely with internal and external manufacturing sites, Customer Service, Medical Information, Pharmacovigilance, Sales, Regulatory, Commercial Operations, Legal, and Risk Management teams.
- Evaluation and Risk Assessment: Assess complaints for severity and risk, ensuring timely review and processing.
- Database Management: Prioritize and log complaints into the global database, monitoring activity for assigned manufacturing sites.
- Reporting and Support: Generate monthly reports on complaint activity for manufacturing sites and provide support during audits and regulatory inspections.
- Team Participation: Engage in ad-hoc teams addressing product-specific complaint issues, offering feedback on complaint investigations.
- Operational Focus: Concentrate on operational tasks within the complaint handling process.
- Continuous Improvement: Identify and implement opportunities for continuous improvement.
- Regulatory Guidance: Provide regulatory interpretation and guidance to internal teams.
- Training Oversight: Manage and oversee departmental training.
- Quality Checks: Conduct quality checks on PQC activities, prepare reports, and maintain inspection readiness.
Candidate Profile
- Education: Bachelor’s or Master’s degree in Life Sciences, Healthcare, Business Administration, Engineering, or Information Technology.
- Experience: 8-10 years of relevant experience in the pharmaceutical industry.
- Knowledge: Familiarity with cGMPs, Code of Federal Regulations for drugs and biologics, and proficiency with complaint database software and reporting tools.
- Quality Functions: Thorough understanding of quality functions within the pharmaceutical industry.
- Manufacturing Experience: Experience working on manufacturing sites is an added advantage.
- Skills: Strong problem-solving skills, attention to detail, and organizational abilities. Ability to work in a team-oriented, flexible, and proactive manner.
- Multitasking: Analytical skills and capacity to multitask in a stressful environment.
Additional Information
- Experience: 8-10 years
- Qualification: Bachelor’s or Master’s degree in Life Sciences/Healthcare
- Location: Hyderabad
- Industry Type: Pharma / Healthcare / Clinical Research
- Functional Area: Product Complaints
- End Date: 30th June 2024
Join us in this critical role to ensure product quality and safety, and to make a significant impact on our global operations.
