Fortrea Hiring Safety Science Analyst
Position Name: Safety Science Analyst
Organization: Fortrea
Location: Bangalore
Salary: ₹4.8 Lakhs
Qualifications:
- B.Pharm, M.Pharm, Pharm.D, MSc, BSc, Life Sciences
Experience: 0 to 2 Years
About Fortrea:
Fortrea is a leading global contract research organization (CRO) known for its scientific rigor and decades of clinical development experience. We provide comprehensive clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With over 19,000 staff operating in more than 90 countries, Fortrea is dedicated to transforming drug and device development for our partners and patients worldwide.
Role Overview:
As a Safety Science Analyst, you will support Clinical Safety and/or PSS operations for various products, including managing adverse events from clinical trials and post-marketing settings. You will ensure the expeditious handling and processing of adverse events to meet client and regulatory requirements within agreed timelines.
Key Responsibilities:
- Case Intake and Triage:
- Receive and triage incoming safety reports from various sources.
- Adverse Event Processing:
- Data entry of safety data into adverse event tracking systems.
- Write patient narratives and code adverse events using MedDRA.
- Perform listedness assessment against appropriate labels for marketed products.
- Generate queries and collect missing or discrepant information in consultation with medical staff.
- Reporting and Submission:
- Submit expedited SAE reports to clients, regulatory authorities, ethics committees, investigators, 3rd party vendors, partners, and Fortrea project personnel within agreed timelines.
- Database Reconciliation:
- Assist in the reconciliation of databases.
- Quality Management:
- Work within the Quality Management System framework, including SOPs and departmental WIs.
- Maintain supporting files/documentation regarding adverse event reporting requirements in all countries.
- Support upload/archival of case/study/project documentation.
- Collaboration and Compliance:
- Build and maintain good PSS relationships across functional units.
- Support compliance of operations with governing regulatory requirements.
- Perform all other duties as needed or assigned.