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Fortrea is hiring a Safety Science Coordinator I in Pune. This role is ideal for life science graduates (BPharm, MPharm, PharmD) with 2+ years of pharmacovigilance or clinical safety experience. If you’re passionate about adverse event reporting, regulatory submissions, and patient safety, this is your chance to join a global CRO leader.
Key Responsibilities
As a Safety Science Coordinator I, you will:
- Assist in processing Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs).
- Maintain adverse event tracking systems and ensure timely reporting.
- Perform data entry, patient narratives, and MedDRA coding for safety cases.
- Assess listedness for marketed products.
- Generate queries for missing or discrepant safety data.
- Submit expedited SAE reports to clients, regulators, and investigators.
- Participate in peer review of processed reports and database reconciliations.
- Ensure compliance with SOPs, Work Instructions, and regulatory guidelines.
- Provide training and mentorship to PSS Assistants and peers.
- Support preparation of safety study files for archiving.
Required Qualifications
- Education: BPharm, MPharm, or PharmD (Fortrea may consider equivalent experience).
- Experience: Minimum 2 years in pharmacovigilance, safety case processing, or CRO industry.
- Skills:
- Strong knowledge of AE/SAE reporting and regulatory submissions.
- Proficiency in safety databases, MedDRA coding, and MS Office.
- Excellent written and spoken English.
- Attention to detail and logical problem-solving.
- Team-oriented mindset with multitasking abilities.
Benefits of Joining Fortrea
- Opportunity to work on global clinical safety projects.
- Exposure to regulatory compliance and pharmacovigilance best practices.
- Professional development and career growth in drug safety.
- Collaborative work culture with international teams.
- Competitive salary and benefits package.
How to Apply
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