Safety Science Analyst
Locations: Pune, India
Time Type: Full-time
Job Requisition ID: 2368328
These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills, and duties*.
As a Safety Science Analyst, you will play a crucial role in ensuring the safety and well-being of patients in clinical trials and the post-marketing phase. Your responsibilities will include the following:
- Case Intake and Triage: Efficiently handle the incoming safety information or reports from various sources, including clinical trials.
- Adverse Event Processing: Take charge of processing adverse events, including:
- Data entry of safety information into adverse event tracking systems.
- Writing patient narratives.
- Accurate coding of adverse events using MedDRA (for Marketed products, if applicable).
- Assessing the listedness of events against appropriate labels (for Marketed products, if applicable).
- Generating queries and collecting missing or discrepant information in consultation with medical staff, if necessary.
- Submit expedited Serious Adverse Event (SAE) reports to various stakeholders within agreed timelines.
- Regulatory Reporting: Assist with processing and submission of expedited and periodic reports to worldwide regulatory agencies and other recipients, ensuring compliance with specific timelines.
- Database Reconciliation: Help in the reconciliation of databases as necessary.
- Quality Management: Work within the Quality Management System framework, which includes adherence to Standard Operating Procedures (SOPs) and departmental Work Instructions (WIs).
- Documentation: Maintain supporting files/documentation related to adverse event reporting requirements.
- File Management: Support the upload and archival of case/study/project documentation.
- Stakeholder Relations: Build and maintain positive relationships across functional units within the organization.
- Regulatory Compliance: Ensure that operations comply with governing regulatory requirements.
- Additional Responsibilities: Perform any other duties as assigned by management.
- The specific job duties are assigned to staff based on their roles and responsibilities.
Fortrea is proud to be an Equal Opportunity Employer:
Fortrea is an Equal Opportunity Employer (EOE) that values diversity and inclusion. We are committed to fostering a workplace that is free from harassment or discrimination of any kind. Employment decisions are based on business needs and individual qualifications, without discrimination based on race, religion, color, national origin, gender, pregnancy, family or parental status, marital status, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other legally protected characteristic.
We encourage candidates from all backgrounds to apply and join our diverse and inclusive workforce.