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21 hours ago
We are seeking a skilled professional to join our Global Patient Safety organization as a Product Complaints Triage Specialist. This critical role involves the intake and triage of product complaints, adverse events, and other safety findings.
Responsibilities- Triage & Intake: The successful candidate will be responsible for the global triage of Product Complaints, ensuring proper Adverse Events and/or Other Safety Findings are captured. They will perform initial data entry (book-in) and append additional information as it's received in the global intake system.
- Compliance & Quality: The Product Complaints Triage Specialist will ensure compliance with global and local procedural documents and implement Standard Operating Procedure requirements for the triage process. They will be responsible for the quality of all PC, AE, and OSF records.
- Collaboration & Timelines: The candidate will work within the Quality Management System framework and have the ability to successfully manage their workload to strict timelines. This role supports a performance-emphasized culture and requires a demonstrated ability to deliver high-quality results consistently.
- System & Process Management: The specialist will use a corporate intake system or safety database to perform their tasks. They will also support the implementation of policies and processes, ensuring that pharmacovigilance and quality operating standards are met.
- A Master's degree or a Bachelor's degree with a background in Drug Safety or Life Sciences.
- Previous experience in a corporate intake system or safety database is preferred.
- Experience in pharmacovigilance or quality in the biotech, pharmaceutical, or medical device industry is a plus.
- An understanding of applicable global regulatory requirements (Good Manufacturing Practices, Good Pharmacovigilance Practices) is preferred.
- Attention to Detail: Ensures quality of PC, AE, and OSF records and accurate data entry.
- Time Management: The ability to successfully manage your workload to meet strict timelines.
- Collaboration: The ability to operate in a matrixed or team environment.
- Problem-Solving: A demonstrated ability to consistently deliver high-quality results.
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