Are you passionate about pharmacovigilance, clinical safety, and regulatory compliance?
Fortrea is hiring a Safety Science Coordinator II in Pune, Indiaโa great opportunity for life science professionals with 2โ3 years of experience in clinical trial case processing or safety data management.
This full-time role involves managing adverse event reports, ensuring timely submissions to regulatory bodies, and maintaining high-quality safety documentation. If you have a strong eye for detail and a background in pharmacy, medical sciences, or life sciences, this could be your next career move.
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Key Responsibilities
As a Safety Science Coordinator II, you will:
- Process and manage adverse event reports from clinical trials and post-marketing sources.
- Perform data entry, medical coding (MedDRA), and narrative writing for safety cases.
- Identify missing or clinically significant data and raise follow-up queries.
- Ensure compliance with global regulatory timelines for expedited reporting.
- Submit safety reports to clients, regulatory authorities, and ethics committees.
- Support database reconciliation, ESR/PSR preparation, and project file management.
- Assist in audits, quality reviews, and staff mentoring.
- Maintain study-level documentation and SOP compliance.
Qualifications and Experience
Education:
- Bachelorโs or Masterโs degree in Biological Sciences, Pharmacy, Nursing, Medical Sciences, or Life Sciences.
Experience:
- 2โ3 years of relevant experience in pharmacovigilance or clinical trial case processing.
- Strong attention to detail and accuracy.
- Proficient in MS Office and safety database systems.
- Excellent communication skills and ability to work both independently and collaboratively.
- Prior experience in adverse event data entry and reporting preferred.
Why Join Fortrea?
- Work with a global leader in clinical research and pharmacovigilance.
- Opportunity to enhance your expertise in drug safety and clinical operations.
- Supportive team environment with hybrid work flexibility.
- Competitive compensation and growth prospects in a dynamic healthcare sector.
How to Apply
