Position: Safety Science Coordinator – 1
Organization: Fortrea
Qualification: B.Pharm, M.Pharm, M.Sc, B.Sc, Pharm.D, Life Sciences
Experience: 0 Years / Freshers
Salary: ₹5 LPA
Location: Pune, India
Key Responsibilities
- Case Intake and Triage: Manage the intake and triage of incoming safety information or reports from various sources, including spontaneous reports and clinical trials.
- Adverse Event Processing:
- Data entry of safety data into adverse event tracking systems.
- Write patient narratives and accurately code adverse events using MedDRA.
- Assist in listedness assessments against appropriate labels for marketed products, if applicable.
- Query Generation and Data Collection: Generate queries and collect missing or discrepant information in consultation with medical staff as needed.
- SAE Report Submission: Submit expedited SAE reports to clients, regulatory authorities, ethics committees, investigators, third-party vendors, partners, and Fortrea project personnel within agreed timelines.
- Report Processing and Submission: Assist in the processing and submission of expedited and periodic reports to worldwide regulatory agencies and other recipients. Ensure adherence to regulatory and study-specific timelines. Prioritize reports for processing and submission as required.
- Database Reconciliation: Assist in the reconciliation of databases as applicable.
- Quality Management: Work within the Quality Management System framework, including adherence to Standard Operating Procedures (SOPs) and departmental Work Instructions (WIs).
- Documentation Maintenance: Assist in maintaining supporting files/documentation regarding adverse event reporting requirements in all countries, if applicable. Support the upload and archival of case/study/project documentation as appropriate.
- Relationship Building: Build and maintain positive relationships across functional units within PSS. Support compliance of operations with governing regulatory requirements.
Candidate Profile:
Fortrea is seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. We are dedicated to revolutionizing the development process and ensuring the swift delivery of life-changing therapies to patients. If you are looking to join an exceptional team and embrace a collaborative workspace where personal growth is nurtured, Fortrea is the place for you.
Qualifications
| Qualification | Details |
|---|---|
| Degree | B.Pharm, M.Pharm, M.Sc, B.Sc, Pharm.D, Life Sciences |
| Experience | Freshers welcome |
Meta Description: Fortrea hiring Safety Science Coordinator in Pune. Freshers welcome. ₹5 LPA salary. Apply now!