Fortrea Hiring Safety Science Analyst

Fortrea Hiring Safety Science Analyst in Pune, India

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 Pune, India, is offering an exciting opportunity for individuals who are ready to make a difference in the field of drug safety.

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.

• Assist with the overall Clinical Safety and/or PSS operations associated with products including the entire adverse events process, which may include safety data collected from clinical trials and/or post marketing settings (i.e., unsolicited reports). Manage and process expeditable adverse events to the required standard and submit them to the client and/or the regulatory agencies (if required) within the agreed/stated timelines. Responsible for providing this service to clients either as a support function to the client project groups or as stand- alone business. Responsible to provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner. The role will be expected to comply with the legal requirements of the Health & Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health & Safety Manual.

Safety Science Analyst

• Locations: Pune, India
• Time Type: Full-time
• Job Requisition ID: 2363078

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.

• • 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.

1. Perform case intake and triage of the incoming safety information or reports from various sources either spontaneously or from a clinical trial.
2. Assist with processing of the adverse events, including but not limited to:
3. Data entry of safety data onto adverse event tracking systems.
4. Write patient narratives & code adverse events accurately using MedDRA (for Marketed products, if applicable).
5. Assist in the listedness assessment against appropriate label (for Marketed products, if applicable).
6. Assist in generation of queries and collection of missing or discrepant information in consultation with medical staff, if needed.
7. Submission of expedited SAE reports to clients, regulatory authorities, ethics committees, investigators, 3rd party vendors, Partners and Fortrea project personnel, as required within the agreed timelines.
8. Assist with processing and submission of expedited and periodic reports to worldwide regulatory agencies or other recipients (Clients, Regulatory Authorities, Ethics Committees, investigators and Fortrea project personnel etc.), and prioritize the reports for processing and submission within the regulatory and/or study specific applicable timelines.
9. Assist in the reconciliation of databases, as applicable.
10. Work within the Quality Management System framework, including but not limited to Standard Operating Procedure (SOP), departmental Work Instructions (WIs) etc. as appropriate.
11. Assist in the maintenance of supporting files/ documentation regarding adverse event reporting requirements in all countries, if applicable.
12. Support upload/archival of case/study/project documentation, as appropriate.
13. Build and maintain good PSS relationships across functional units.
14. Support compliance of operations with governing regulatory requirements.

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

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