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Safety Data Coordinator
hace 2 semanas
The Adverse Event Intake Coordinator plays a pivotal role in ensuring the timely and accurate processing of adverse event reports related to our company's products. This position is responsible for receiving, reviewing, and processing incoming adverse event reports from various sources, including healthcare professionals, consumers, and regulatory agencies.
Key Responsibilities:- Receive, review, and triage incoming AE reports from various sources.
- Create, maintain, and track case folders; file, retrieve, and distribute case folders to operations team members.
- Perform ICSR surveillance on administrative topics and process including collection, reporting, follow-up processes.
- Accurately enter AE data into the company's safety database.
- Conduct initial case assessment and assign appropriate case status.
- Track and monitor the progress of AE investigations.
- Prepare case narratives and other relevant documentation.
- Assist with the preparation of safety reports for regulatory submissions.
- Assist in maintaining document control storage and relevant applications/systems as directed.
- Provide key input to operations team on acquisition and/or upgrade of records management application/systems.
- Ensure the accuracy and completeness of all AE data.
- Perform data entry and validation checks.
- Maintain accurate records and documentation.
- Support periodic audits and quality control checks on case processing activities.
- Communicate effectively with internal and external stakeholders, including medical professionals, regulatory agencies, and other departments within the company.
- Collaborate with other team members to ensure timely and efficient case processing.
- Respond to inquiries and requests for information in a timely and professional manner.
- Ensure compliance with all relevant regulatory requirements, including Good Pharmacovigilance Practices (GVP) and local regulations.
- Stay informed of any changes to relevant regulations and guidelines.
