Safety Science Coordinator II
Safety Science Coordinator II
Fortrea
Job description
Looking to build a career in clinical safety and pharmacovigilance? Explore this Safety Science Coordinator II role at Fortrea.
Company Description
Fortrea is a clinical research company that works to bring life‑saving therapies to patients everywhere. The company believes that teamwork and shared commitment can make the impossible possible. Fortrea backs trials and drug development with solid scientific expertise and dependable service. With a culture that values collaboration it keeps pushing barriers in modern clinical research.
Job Summary
This role supports Clinical Safety and PSS operations tied to adverse event processing. As a Safety Science Coordinator II, you will manage safety data from clinical trials and post marketing reports. Your work will include data entry, narrative writing, and expedited reporting to regulatory agencies. The role also involves maintaining documentation, supporting audits, and mentoring newer PSS team members when needed.
Key Responsibilities
Process adverse event reports from clinical trials or spontaneous sources.
Enter safety data accurately into adverse event databases and tracking systems.
Review adverse events for completeness, accuracy, and expedited reporting needs.
Write patient narratives and code adverse events using MedDRA.
Spot missing clinical information and raise queries to collect it.
Ensure cases receive proper medical review before submission.
Prioritize and submit expedited safety reports within required timelines.
Submit reports to clients, regulatory authorities, ethics committees, and investigators.
Process Expedited and Periodic Safety Reports, including tracking and documentation.
Maintain project files and central documentation systems accurately.
Support quality checks and peer review of processed safety reports.
Assist with database reconciliation and related safety activities.
Maintain project level documentation as required by each study.
Support training and mentoring of newer PSS staff members.
Help prepare monthly status reports and safety related metrics.
Stay updated on SOPs, work instructions, and pharmacovigilance guidelines.
Support client meetings and communication, where appropriate.
Assist with quality issue management and audit preparation.
Ensure all safety operations follow required regulatory standards.
Take on additional duties as assigned by management.
Educational Qualification
Degree preferred in Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or a related field.
Accepted combinations include a non degree with relevant safety experience, an associate degree with experience, a Bachelor's, Master's, or PharmD with at least 1 year of relevant experience.
Skills Required
High level of accuracy and strong attention to detail.
Good team collaboration and willingness to support peers.
Strong written and verbal communication skills.
Ability to work independently with moderate supervision.
Good computer skills, including MS Office and Windows applications.
Mentoring skills are preferred, though not mandatory.
Salary Structure
The estimated annual salary for a Safety Science Coordinator II at Fortrea in India typically ranges from ₹5.5 to ₹6.0 LPA.
Career Development
This role gives you hands-on experience, in clinical safety and pharmacovigilance at a well-known research organization. Fortrea also helps you grow over the term by offering mentorship and a supportive team-focused environment.
How to Apply
Visit our job portal and search for the Safety Science Coordinator II role - Fortrea.
Click on the job posting to read all the details, about the job.
Fill in your details. Upload your updated resume.
Send your application.
Education
Bachelor's Degree
Key Skills
Market insights & trends
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