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Fortrea is a leading global contract research organization (CRO) specializing in clinical development and patient access solutions. With a strong focus on pharmacovigilance, clinical safety, and regulatory compliance, Fortrea partners with pharmaceutical and biotech companies to ensure drug safety and efficacy.
Detailed Job Description
1. Safety Science Coordinator I
Key Responsibilities:
- Assist in processing Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs).
- Maintain adverse event tracking systems and ensure timely submissions to regulatory authorities.
- Perform data entry, narrative writing, and MedDRA coding for adverse events.
- Support quality reviews, database reconciliation, and compliance with SOPs.
- Train and mentor junior team members in pharmacovigilance processes.
Eligibility:
- Education: PharmD/MPharm/BPharm + 2 years of relevant experience (Pharmacovigilance, Clinical Research, Regulatory Affairs).
- Preferred Background: Pharmacy, Nursing, Life Sciences, or Medical Sciences.
- Skills Required: Attention to detail, strong communication, proficiency in MS Office.
2. Associate II PSS (Pharmacovigilance Safety Specialist)
Key Responsibilities:
- Manage adverse event (AE/SAE) reports from clinical trials and post-marketing surveillance.
- Conduct medical review, listedness assessment, and regulatory submissions within timelines.
- Perform database reconciliation and support audits/inspections.
- Generate safety metrics and assist in root cause analysis for quality issues.
Eligibility:
- Experience: Prior work in pharmacovigilance, clinical data management, or regulatory affairs.
- Technical Skills: MedDRA coding, safety databases, and regulatory reporting.
- Soft Skills: Team collaboration, problem-solving, and multitasking.
Benefits of Working at Fortrea
✅ Competitive salary & benefits package
✅ Career growth in pharmacovigilance & clinical research
✅ Exposure to global regulatory standards (FDA, EMA, ICH-GCP)
✅ Collaborative work environment with training & mentorship
How to Apply
📍 Location: Pune, India
📅 Last Date to Apply: July 23, 2025
🔗 Job IDs: 253905 (Safety Science Coordinator I) | 253918 (Associate II PSS)
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Application Link For Safety Science Coordinator I
Application Link For Associate II PSS
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