[Freshers + 5 LPA] Fortrea Hiring Safety Science Coordinator apply now

About Company

As a leading global contract research organization (CRO), Fortrea combines scientific rigor with extensive clinical development experience. We offer pharmaceutical, biotechnology, and medical device clients a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With a dedicated team of over 19,000 staff members operating in more than 90 countries, Fortrea is committed to transforming drug and device development for our partners and patients worldwide.

Position Name : Safety Science Coordinator -1

Organization : Fortrea

Qualification: B.Pharm, M.Pharm, Msc, Bsc, Pharm.D, Lifesciences

Experience: 0 YEARS / Freshers

Salary: 5 lacs Per Year

Location: Pune, India

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 for marketed products, if applicable.
- 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, ensuring 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.