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Fortrea is inviting applications for the position of Assistant I – PSS (Pharmacovigilance & Safety Services) at its Pune location. This is a full-time hybrid role, offering a great opportunity for fresh graduates and early-career professionals to build their careers in the clinical safety and pharmacovigilance domain.
Job Details
- Position: Assistant I – PSS
- Location: Pune (Hybrid)
- Job Type: Full-time
- Application Deadline: October 6, 2025
- Job Requisition ID: 254803
Job Overview
As an Assistant I – PSS at Fortrea, you will support Clinical Safety and PSS operations across clinical trials and post-marketing settings. The role primarily involves managing adverse events (AE/SAE) data, ensuring accurate documentation, and submitting reports to clients, regulatory authorities, and other stakeholders within required timelines.
This position is ideal for candidates eager to gain experience in pharmacovigilance, safety reporting, and regulatory compliance within the pharmaceutical and CRO industry.
Key Responsibilities
- Intake and triage of incoming safety information/reports.
- Enter safety data into adverse event tracking systems.
- Prepare patient narratives and code events using MedDRA.
- Conduct listedness assessments (for marketed products).
- Generate queries and coordinate with medical staff for missing/discrepant information.
- Submit expedited SAE reports to regulatory authorities, clients, investigators, and other stakeholders.
- Assist in database reconciliation and periodic safety reporting.
- Maintain compliance with SOPs, regulations, and quality management systems.
- Archive study and project-related safety documents.
- Support internal and external client relationships within PSS.
Qualifications
Qualifications (Minimum Required):
- Non-Degree or 6 months – 1 year of Safety experience* or relevant experience **
- Associate Degree with 0-6 months of Safety experience* or relevant experience**
- BS/BA with 0- 6 months of Safety experience* or relevant experience**
- MS/MA with 0 yrs. of Safety experience* or relevant experience**
- PharmD with 0 yrs. of Safety experience* or relevant experience**
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
- To be used in lieu of experience, Degree required to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related area *Safety experience includes actual experience of processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.
- ** Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, working in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitoring, Regulatory Affairs, or Quality Assurance.
Skills Required
- Strong attention to detail and data accuracy
- Excellent written and verbal communication
- Ability to work effectively in a team environment
- Knowledge of MS Office applications
- Aptitude for handling and proofreading numerical data
Why Join Fortrea?
Fortrea offers a platform to start and grow your career in pharmacovigilance and clinical safety services. As part of a global team, you will contribute to ensuring patient safety, regulatory compliance, and high-quality service delivery across the life sciences sector.
📅 Last Date to Apply: October 6, 2025
