Fortrea is hiring for the position of Associate I – PSS in Bangalore. The role focuses on Patient Safety Services (PSS), clinical safety operations, adverse event processing, pharmacovigilance reporting, and regulatory submissions.
Candidates with qualifications in Pharmacy, Pharm.D, Biological Sciences, Nursing, Medical Sciences, Life Sciences, or related disciplines can apply, subject to the relevant experience requirements.
Job Details
| Particulars | Details |
|---|---|
| Company | Fortrea |
| Job Title | Associate I – PSS |
| Job Location | Bangalore, India |
| Experience | As per qualification and experience criteria |
| Job Category | Pharmacovigilance / Patient Safety Services |
| Work Environment | Office or Remote |
| Job Posted Date | 30 October 2026 |
Position
Associate I – PSS (Patient Safety Services)
The selected candidate will support clinical safety and pharmacovigilance operations, including adverse event case processing, safety database management, expedited safety reporting, and compliance with applicable regulatory requirements.
Key Responsibilities
- Process adverse event reports from clinical trials and post-marketing sources according to client and sponsor requirements.
- Receive, review, and process spontaneous and clinical trial adverse event reports.
- Enter safety information into adverse event databases and tracking systems.
- Review adverse event reports for completeness, accuracy, and expedited reporting requirements.
- Prepare patient narratives and accurately code adverse events using MedDRA, where applicable.
- Identify missing clinically significant information and generate queries for additional information.
- Ensure appropriate medical review of safety cases.
- Prioritize and process expedited safety reports within applicable regulatory and study-specific timelines.
- Submit expedited SAE reports to clients, regulatory authorities, ethics committees, investigators, and other relevant recipients.
- Process Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs).
- Maintain tracking systems, project files, and safety documentation.
- Support quality reviews and peer reviews of processed reports.
- Assist with database reconciliation and related activities.
- Maintain study-level and project-level documentation.
- Support staff training, mentoring, and peer assistance.
- Assist in preparing monthly status reports and maintaining PSS performance metrics.
- Follow applicable SOPs, work instructions, pharmacovigilance guidelines, and regulatory requirements.
- Support client meetings, quality issue management, and audit and inspection preparation.
Eligibility and Qualifications
Candidates must meet one of the following qualification and experience requirements:
| Qualification | Minimum Experience |
|---|---|
| Non-degree | 1 year of Safety experience or 3 years of relevant experience |
| Associate Degree | 1 year of Safety experience or 2 years of relevant experience |
| BS/BA | 1 year of relevant experience |
| MS/MA | 1 year of relevant experience |
| Pharm.D | 1 year of relevant experience |
Preferred educational backgrounds:
- Biological Sciences
- Pharmacy
- Nursing
- Medical Sciences
- Life Sciences
- Related disciplines
For Pharm.D candidates, a one-year residency or fellowship can be considered relevant experience.
Required Skills
- Strong attention to detail and high accuracy in work.
- Good written and verbal communication skills.
- Ability to work independently with moderate supervision.
- Teamwork and peer-support capabilities.
- Good keyboard skills.
- Knowledge of MS Office and Windows applications.
- Mentoring skills are preferred.
