Company: Fortrea
Location: Bangalore
Position: Safety Science Analyst
Salary: ₹4.8 Lakhs
Experience: 0 to 2 Years
Qualification: B.Pharm, M.Pharm, Pharm.D, MSc, BSc, Lifesciences
About the Company
Fortrea is a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience. We provide pharmaceutical, biotechnology, and medical device customers with a wide range of 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 transforming drug and device development for partners and patients worldwide.
Position Details
| Position Name | Safety Science Analyst |
|---|---|
| Organization | Fortrea |
| Location | Bangalore |
| Salary | ₹4.8 Lakhs |
| Experience | 0 to 2 Years |
| Qualification | B.Pharm, M.Pharm, Pharm.D, MSc, BSc, Lifesciences |
Key Responsibilities
- Perform case intake and triage of incoming safety information or reports from various sources.
- Assist with processing adverse events, including data entry, writing patient narratives, and coding adverse events using MedDRA.
- Conduct listedness assessment against appropriate labels for marketed products.
- Generate queries and collect missing or discrepant information in consultation with medical staff.
- Submit expedited SAE reports to clients, regulatory authorities, ethics committees, investigators, 3rd party vendors, partners, and Fortrea project personnel within agreed timelines.
- Assist in the reconciliation of databases.
- Work within the Quality Management System framework, including Standard Operating Procedures (SOP) and departmental Work Instructions (WIs).
- Maintain supporting files/documentation regarding adverse event reporting requirements in all countries.
- Support upload/archival of case/study/project documentation.
- 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.
Apply now to join Fortrea and contribute to our mission of transforming drug and device development!