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Fortrea is inviting applications for the role of Safety Science Coordinator I in Pune, offering an excellent opportunity for freshers and early-career professionals in pharmacovigilance, drug safety, and clinical research operations. This position focuses on end-to-end adverse event management, safety reporting, data processing, and regulatory submissions—ideal for candidates looking to build a strong foundation in global safety operations.
Key Responsibilities
As a Safety Science Coordinator I, you will:
Safety Case Processing & Reporting
- Assist in processing Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs).
- Manage AE/SAE case flow, including logging, triaging, and routing.
- Enter safety data into adverse event tracking systems.
- Write patient safety narratives and code AEs using MedDRA (for marketed products where applicable).
- Conduct listedness assessment for marketed products.
Regulatory Submissions
- Submit expedited SAE reports to:
- Clients
- Regulatory Authorities
- Ethics Committees
- Investigators
- Third-party vendors
- Ensure submissions meet study-specific and regulatory timelines.
Quality & Compliance
- Maintain adverse event tracking systems and project documentation.
- Participate in quality review of processed reports.
- Support database reconciliation activities.
- Work within SOPs and Quality Management Systems (QMS).
- Prepare study files for archiving upon project completion.
Coordination & Support
- Schedule meetings/teleconferences.
- Provide administrative support to PSS teams.
- Mentor junior PSS assistants in routine activities.
- Build strong cross-functional relationships.
Qualifications
Minimum Educational Requirements:
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- Non-Degree with 1–2 years of safety or relevant experience
- Associate Degree with 6 months–1 year experience
- BS/BA with 0–1 year experience
- MS/MA / PharmD with 0–6 months experience
- Disciplines preferred: Biological Sciences, Pharmacy, Nursing, Life Sciences, Medical Sciences
Relevant Experience Includes:
- AE/SAE case processing
- Narrative writing
- Safety database operations
- Regulatory submissions
- Clinical Data Management, PV operations, QMS, Medical Affairs
Core Skills
- Strong attention to detail
- Ability to manage multiple priorities
- Excellent communication skills (written & verbal)
- Logical and numerical reasoning
- Proficiency in MS Office and safety database tools
- Team collaboration skills
Work Environment
- Office or Remote (depending on project requirements)
Benefits
While specific benefits are not listed in the JD, Fortrea typically offers:
- Competitive salary and annual performance review
- Medical insurance and wellness programs
- Employee assistance programs
- Career growth in clinical and safety operations
- Work-life balance with flexible work arrangements
How to Apply
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