Pharmaceutical Career Jobs at Fortea | Apply Now for Safety Science Coordinator I Role
Fortrea, a global leader in clinical research and life sciences solutions, is seeking a detail-oriented Safety Science Coordinator I to join its team in Pune. This is a full-time opportunity to work on critical safety operations for pharmaceutical and biotechnological products, from processing adverse events to ensuring regulatory compliance. If you have a background in pharmacy or life sciences and a passion for safeguarding patient safety, this role offers the perfect blend of scientific responsibility and professional growth.
- Job Position: Safety Science Coordinator I
- Location: Pune, India
- Job Requisition ID: 254405
About the Company
Fortrea is a leading global provider of clinical development and patient access solutions. With expertise spanning the pharmaceutical, biotechnology, and medical device industries, Fortrea helps bring new treatments to patients more quickly by combining deep scientific knowledge with operational excellence. The company’s collaborative approach and advanced technology platforms ensure high-quality outcomes while maintaining the highest standards of safety and compliance.
Job Description
As a Safety Science Coordinator, you will assist with clinical safety and pharmacovigilance operations for products in both clinical trials and post-marketing settings. Your responsibilities will include processing adverse event data, maintaining safety databases, preparing regulatory submissions, and supporting clients to ensure timelines and quality standards are met. This role requires adherence to international safety regulations and Fortrea’s internal quality systems.
Key Responsibilities
- Process Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs).
- Maintain adverse event tracking systems and project documentation.
- Log incoming AE/SAE reports and ensure timely forwarding to relevant teams.
- Write patient narratives and accurately code events using MedDRA.
- Assess listedness against product labeling (for marketed products).
- Generate and resolve queries for missing or inconsistent safety data.
- Submit SAE reports to regulatory bodies, ethics committees, and clients.
- Assist with peer review of processed reports and identify trends.
- Support reconciliation of safety databases and maintain reporting requirements.
- Arrange and coordinate internal/external meetings.
- Mentor peers and provide support to PSS personnel.
Qualifications Required:
- PharmD, MPharm, or BPharm with at least 2 years of relevant experience.
- Degree in Pharmacy, Nursing, Medical Sciences, Life Sciences, or related field.
- Hands-on experience in AE/SAE processing, safety databases, narratives, queries, and regulatory submissions.
- Strong attention to detail, organizational skills, and ability to manage multiple tasks.
- Proficiency in English (spoken, written, and reading).
Preferred:
- Experience in the pharmaceutical, biotechnology, or CRO industries.
- Familiarity with MS Office and safety data handling tools.
Benefits of Joining
- Opportunity to work with a global leader in clinical research and patient safety.
- Exposure to diverse projects across pharmaceuticals and biotech.
- Collaborative work culture with peer support and mentoring.
- Professional growth in a regulated, high-quality operational environment.
- Competitive compensation and benefits package.
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