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Fortrea is hiring for the Assistant I PSS role in Pune, India. This is a golden opportunity for life sciences, pharmacy, and medical graduates to begin or advance their career in pharmacovigilance, drug safety, and clinical research operations.
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The position offers exposure to adverse event processing, regulatory submissions, and clinical safety systems, making it a perfect stepping stone into the pharmaceutical and CRO industry.
Key Responsibilities
As an Assistant I PSS, you will:
- Perform intake and triage of safety information from clinical trials and post-marketing sources.
- Process adverse event (AE/SAE) reports, including data entry, patient narratives, and MedDRA coding.
- Assist in listedness assessments and generation of safety queries.
- Submit expedited reports to regulatory authorities, clients, ethics committees, and investigators.
- Support periodic safety reporting and case reconciliation.
- Maintain compliance with SOPs, Work Instructions, and global safety regulations.
- Build strong cross-functional relationships within PSS and clinical teams.
Required Qualifications
- Education:
- Non-degree with 6 months–1 year safety experience, OR
- Associate/BS/MS/PharmD in Biological Sciences, Pharmacy, Nursing, Medical Sciences, or related fields.
- Experience:
- 0–1 year of experience in safety case processing, regulatory submissions, or relevant pharma/CRO domains (clinical data management, regulatory affairs, QA).
- Skills:
- Strong attention to detail, communication, and teamwork.
- Proficiency in MS Office and safety database tools.
- Aptitude for handling medical and numerical data accurately.
Benefits of Joining Fortrea
- Hybrid work flexibility (Pune-based).
- Opportunity to work with global clients and regulatory agencies.
- Professional development in pharmacovigilance and safety operations.
- Inclusive workplace supporting growth and learning.
How to Apply
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