Join Fortrea as a Safety Science Analyst in Pune – Your Opportunity Awaits! Apply Now.
About Fortrea :
Fortrea is a dynamic and innovative company that specializes in the field of safety science and regulatory reporting. Dedicated to providing solutions for processing and managing safety information and reports, particularly in the context of clinical trials and healthcare, Fortrea is committed to maintaining the highest standards of quality and compliance with regulatory requirements. This work plays a crucial role in ensuring the safety and well-being of patients and the effectiveness of healthcare products.
Job Overview :
Job Title: Safety Science Analyst
Location: Pune, India
Time Type: Full-time
Description :
As a Safety Science Analyst, you will play a crucial part in processing safety information and reports from various sources, including clinical trials. Your responsibilities will include:
- Case intake and triage of incoming safety information or reports.
- Processing adverse events data, which involves data entry, patient narrative writing, and accurate coding using MedDRA (for Marketed products, if applicable).
- Assessing listedness against appropriate labels (for Marketed products, if applicable).
- Generating queries and collecting missing or discrepant information in consultation with medical staff when necessary.
- Submitting expedited Serious Adverse Event (SAE) reports to various recipients within agreed timelines.
- Handling the processing and submission of expedited and periodic reports to worldwide regulatory agencies and other relevant parties.
- Prioritizing reports for submission within specific regulatory and study timelines.
- Assisting in database reconciliation.
- Working within the Quality Management System framework, which includes following Standard Operating Procedures (SOPs) and departmental Work Instructions (WIs).
- Maintaining supporting files and documentation related to adverse event reporting requirements.
- Supporting the upload and archival of case, study, and project documentation.
- Building and maintaining positive relationships across functional units.
- Ensuring operational compliance with governing regulatory requirements.
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How to apply :
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