Sr. Specialist - Quality Services (Product Complaints)

Sanofi

3 - 7 years

4 - 8 Lacs

Hyderabad

Posted:1 week ago| Platform:

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Skills Required

Medical devices Consulting Healthcare Oncology Life sciences Customer service Pharmacovigilance Continuous improvement Risk management Monitoring

Work Mode

Work from Office

Job Type

Full Time

Job Description

Handle Product Technical Complaints and Field Alerts for medical devices, pharmaceutical products, biologics, and combination products, ensuring compliance with regulatory standards.
Manage the entire process of handling Product Technical Complaints and Field Alerts from receipt to closure, ensuring compliance with internal procedures and regulatory requirements.
Collaborate with internal and external manufacturing sites, Customer Service, Medical Information, Pharmacovigilance, Sales Associates, Regulatory, Commercial Operations, Legal, and Risk Management departments.
Evaluate complaints for severity and risk, ensuring timely review and processing. Prioritize and enter complaints into the global database, monitoring complaint activity for assigned manufacturing sites.
Produce monthly reports for manufacturing sites on complaint activity and support during audits and regulatory inspections. Participate in ad-hoc teams for product-specific complaint issues and provide feedback on complaint investigations.
Focus on operational tasks within the compliant handling process. Identify and implement continuous improvement opportunities. Provide regulatory interpretation and guidance to internal teams. Manage and oversee the training within the department. Perform quality checks on PQC activities, prepare reports, and maintain inspection readiness.
Determine if the PTC is associated with an Adverse Event, Pharmacovigilance (PV) Special Situation. Ensure respective teams are communicated (As applicable). Ensure to complete all the required fields in tools and assign the complaint to respective investigation owning site.
Ensure completion of the investigation. Perform final review/update the complaint record and close as per defined timelines. Ensure acknowledgement of Complaint and/or response letter to Complainant (As applicable).
Health authority called-in complaints, prioritized complaints and suspected counterfeit complaints are handled with the utmost urgency and in strict compliance with both global and country-specific regulatory requirement. Maintain compliance with all relevant regulatory requirements for complaint management and reporting. Consulting to FAR team in case of any filed alert expected (as applicable).

About you:

Experience: 3 7 years of related experience in the pharmaceutical industry. Knowledge of cGMP s, Code of Federal Regulations in drugs and biologics, and complaint database software and reporting tools. Should be knowledgeable in Quality functions of pharmaceutical industry. Experience of working on manufacturing sites is an added advantage.
Proficient in problem-solving, attention to detail, and good organizational skills. Work in a team-oriented, flexible, and proactive manner. Analytical skills and ability to multitask in a stressful environment.
Education: bachelors or Masters in Life Sciences/Healthcare, Business Administration, Engineering.
Languages: Verbal and written fluency in English

Why choose us

Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it s through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, we'll-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and we'llbeing benefits including high-quality healthcare, prevention, and we'llness programs and at least 14 weeks gender-neutral parental leave.
Opportunity to work in an international environment, collaborating with diverse business teams and vendors, working in a dynamic team, and fully empowe'red to propose and implement innovative ideas.

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