This job is with Sanofi, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.
Job title : Sr Analyst of Product Complaints
Location: Bogotá, Colombia
About the job
We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Your job, as Sr Analyst of Product Complaints within our team, will be to Manage the entire process of handling Product Technical Complaints and Field Alerts from receipt to closure, ensuring compliance with internal procedures and regulatory requirements.
Main responsibilities:
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.
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.
Produce monthly reports for manufacturing sites on complaint activity and support during audits and regulatory inspections.
Collaborate with internal and external manufacturing sites, Customer Service, Medical Information, Pharmacovigilance, Sales Associates, Regulatory, Commercial Operations, Legal, and Risk Management departments.
Identify and implement continuous improvement opportunities in complaint management.
Provide regulatory interpretation and guidance to internal teams and corporate partners.
Manage and oversee the training within the team.
Perform quality checks on activities, prepare reports, and maintain inspection readiness.
About you
Experience : • 3 - 7 years of related experience in the pharmaceutical industry Knowledge of cGMPs, 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.
Soft skills : 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 : Bachelor's in Life Sciences/Healthcare, Business Administration, Engineering or Information Technology.
Languages : Excellent knowledge of English language (spoken and written).
Why choose us?
Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
You'll be part of leading the first experiences a job seeker has with Sanofi and ensuring it is best-in-class and driving conversions.
You'll be part of a truly diverse cross-cultural team and can have real business impact.
Flexible working policies, including up to 50% remote work.
Private medical care, life and health insurance, and gender-neutral paid parental leave
Colombia is one of Sanofi's key locations for new talents, having a big footprint with the Bogota HUB and its best-in-class operation.
Mexico and Argentina Play an instrumental part in creating best practice and innovation within our 3 vaccines production plants.
Pursue Progress . Discover Extraordinary .
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. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let's pursue progress. And let's discover extraordinary together.
At Sanofi, we provide equal opportunities to 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 and check out our Diversity Equity and Inclusion actions at sanofi.com!
#LI-LAT #LI-HYBRID
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!
#LI-DNI