Fortreaย is a leading global contract research organization (CRO) specializing in clinical development and patient access solutions. With a strong focus onย 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 processingย Expedited Safety Reports (ESRs)ย andย Periodic Safety Reports (PSRs).
- Maintainย adverse event tracking systemsย and ensure timely submissions to regulatory authorities.
- Performย data entry, narrative writing, and MedDRA codingย for adverse events.
- Supportย quality reviews, database reconciliation, and complianceย with SOPs.
- Train and mentor junior team members in pharmacovigilance processes.
Eligibility:
- Education:ย PharmD/MPharm/BPharm +ย 2 years of relevant experienceย (Pharmacovigilance, Clinical Research, Regulatory Affairs).
- Preferred Background:ย Pharmacy, Nursing, Life Sciences, or Medical Sciences.
- Skills Required:ย Attention to detail, strong communication, proficiency in MS Office.
2. Associate II PSS (Pharmacovigilance Safety Specialist)
Key Responsibilities:
- Manageย adverse event (AE/SAE) reportsย from clinical trials and post-marketing surveillance.
- Conductย medical review, listedness assessment, and regulatory submissionsย within timelines.
- Performย database reconciliationย and support audits/inspections.
- Generateย safety metricsย and assist in root cause analysis for quality issues.
Eligibility:
- Experience:ย Prior work inย pharmacovigilance, clinical data management, or regulatory affairs.
- Technical Skills:ย MedDRA coding, safety databases, and regulatory reporting.
- Soft Skills:ย Team collaboration, problem-solving, and multitasking.
Benefits of Working at Fortrea
โ
Competitive salary & benefits package
โ
Career growth in pharmacovigilance & clinical research
โ
Exposure to global regulatory standards (FDA, EMA, ICH-GCP)
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Collaborative work environment with training & mentorship
How to Apply
๐ย Location:ย Pune, India
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ย Last Date to Apply:ย July 23, 2025
๐ย Job IDs:ย 253905 (Safety Science Coordinator I) | 253918 (Associate II PSS)
Application Link For Safety Science Coordinator I
Application Link For Associate II PSS