Fortrea, a leading global contract research organization (CRO), is hiring for the position of Assistant I PSS in Pune. This is a full-time role with an application deadline of March 3, 2025. If you are passionate about clinical safety and pharmacovigilance, this is an excellent opportunity to contribute to groundbreaking clinical trials and make a global impact. Read on to learn more about the job responsibilities, qualifications, and how to apply.
About Fortrea
Fortrea is a trusted name in the pharmaceutical, biotechnology, and medical device industries. With operations in over 100 countries, Fortrea provides comprehensive clinical development, patient access, and technology solutions across 20+ therapeutic areas. The company is dedicated to transforming drug and device development, ensuring faster delivery of life-changing therapies to patients worldwide.
Job Overview – Assistant I PSS
As an Assistant I PSS, you will play a critical role in managing clinical safety and pharmacovigilance operations. Your responsibilities will include processing adverse events (AEs), ensuring compliance with regulatory requirements, and maintaining high-quality safety data. This role is ideal for individuals with a background in biological sciences, pharmacy, or related fields who are looking to build a career in pharmacovigilance.
Key Responsibilities
- Perform case intake and triage of safety reports from clinical trials and post-marketing settings.
- Assist in data entry, coding adverse events using MedDRA, and writing patient narratives.
- Support the submission of expedited SAE reports to clients, regulatory authorities, and ethics committees.
- Ensure compliance with global regulatory requirements and internal quality management systems.
- Collaborate with cross-functional teams to maintain accurate and up-to-date safety documentation.
- Assist in the reconciliation of databases and archival of case/study-related documents.
Qualifications and Experience
Minimum Required Qualifications:
- Non-Degree with 6 months to 1 year of safety experience* or relevant experience**.
- Associate Degree with 0-6 months of safety experience* or relevant experience**.
- BS/BA, MS/MA, or PharmDÂ in Biological Sciences, Pharmacy, Nursing, Medical Sciences, or related fields.
Safety Experience Includes:
- Processing AE/SAE reports.
- Generating narratives and queries.
- Working with safety databases and regulatory submissions.
Relevant Experience Includes:
- Roles in pharmaceutical, biotechnology, or CRO industries.
- Experience in Medical Affairs, Clinical Data Management, Regulatory Affairs, or Quality Assurance.
Skills and Competencies
- Strong attention to detail and accuracy.
- Excellent written and verbal communication skills.
- Proficiency in MS Office and safety databases.
- Ability to work in a team-oriented environment.
- Knowledge of regulatory requirements and pharmacovigilance processes.
