Are you looking to build a rewarding career in drug safety and pharmacovigilance? Fortrea is hiring a Safety Science Analyst in Pune, India. This role is perfect for fresh graduates or professionals with up to 1 year of experience in safety case processing, clinical data management, or regulatory affairs. If you’re passionate about adverse event reporting, patient safety, and compliance with global regulatory standards, this could be your next big career move.
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📌 Key Responsibilities
As a Safety Science Analyst, you will:
- Perform intake and triage of safety information from clinical trials and post-marketing sources.
- Manage adverse event (AE) and serious adverse event (SAE) case processing.
- Enter safety data into AE tracking systems with high accuracy.
- Write patient narratives and code adverse events using MedDRA.
- Support listedness assessments for marketed products.
- Generate queries and liaise with medical staff to resolve discrepancies.
- Submit expedited SAE reports to clients, regulatory bodies, ethics committees, and investigators.
- Assist in periodic safety reporting and database reconciliations.
- Ensure compliance with SOPs, Work Instructions, and global safety regulations.
- Support document archival and cross-functional safety operations.
🎓 Qualifications
- Education:
- BS/BA, MS/MA, PharmD, or equivalent in Biological Sciences, Pharmacy, Nursing, Medical Sciences, or Life Sciences.
- Fortrea may consider relevant industry experience in lieu of a degree.
- Experience:
- Freshers or candidates with 0–1 year of experience in safety case processing, clinical data management, pharmacovigilance, regulatory affairs, or quality assurance.
- Skills:
- Strong attention to detail and accuracy.
- Excellent written and verbal communication skills.
- Knowledge of Microsoft Office applications.
- Ability to work independently and in a team environment.
💼 Benefits of Joining Fortrea
- Work with a global CRO dedicated to advancing clinical research and safety science.
- Exposure to end-to-end pharmacovigilance processes.
- Career development in drug safety, regulatory submissions, and clinical operations.
- Hybrid/office flexibility (Pune location).
- Competitive salary and performance-based growth opportunities.
📍 Job Location
- City: Pune, Maharashtra, India
- Work Type: Full-time (Office/Remote flexibility)
📝 How to Apply
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