Fortrea Hiring Safety Science Analyst

Embarking on a career as a Safety Science Analyst is more than just a job; it’s a commitment to safeguarding the well-being of patients. Fortrea, located in the vibrant city of Bangalore, India, is offering an exciting opportunity for individuals who are ready to make a difference in the field of drug safety.

Who is Fortrea?

Fortrea is a dynamic organization committed to making advancements in drug safety and ensuring the highest standards in healthcare. With a focus on innovation and excellence, Fortrea provides an environment where individuals can thrive and contribute to meaningful work.

The Role of a Safety Science Analyst

As a Safety Science Analyst, your primary responsibility is to perform case intake and triage of safety information from various sources. You play a crucial role in processing adverse events and ensuring the accurate reporting of safety data.

Safety Science Analyst

Locations: Bangalore,India

Time Type: Full-time

Job Requisition ID: 2266988

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*.

Job Description:

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:

1. Case Intake and Triage: Efficiently handle the incoming safety information or reports from various sources, including clinical trials.
2. 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.
3. Regulatory Reporting: Assist with processing and submission of expedited and periodic reports to worldwide regulatory agencies and other recipients, ensuring compliance with specific timelines.
4. Database Reconciliation: Help in the reconciliation of databases as necessary.
5. Quality Management: Work within the Quality Management System framework, which includes adherence to Standard Operating Procedures (SOPs) and departmental Work Instructions (WIs).
6. Documentation: Maintain supporting files/documentation related to adverse event reporting requirements.
7. File Management: Support the upload and archival of case/study/project documentation.
8. Stakeholder Relations: Build and maintain positive relationships across functional units within the organization.
9. Regulatory Compliance: Ensure that operations comply with governing regulatory requirements.
10. 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.

How to Apply for the Safety Science Analyst Position

Ready to embark on a fulfilling career journey with Fortrea?