PSPM Support Associate
Company
Fortrea – A global clinical research organization providing pharmacovigilance, clinical safety, and post-marketing safety support services to ensure compliance and patient safety.
Job Details
Job Title: PSPM Support Associate
Job Requisition ID: 262083
Employment Type: Full-time
Location: Bangalore, India
Application Deadline: May 31, 2026
About the Role
The PSPM Support Associate supports clinical safety and pharmacovigilance operations across clinical trials and post-marketing studies.
This role focuses on processing adverse event reports, supporting safety system activities, and assisting in regulatory compliance to ensure timely and accurate safety reporting to clients and regulatory authorities.
Key Responsibilities
1. Safety & Adverse Event Processing
Support management of:
Adverse event (AE) reporting
Clinical trial safety data
Post-marketing safety reports (unsolicited reports)
Process and submit safety reports to clients and regulatory authorities within required timelines.
2. Study Setup & Maintenance Support
Assist in:
Study setup, maintenance, and close-out activities
System configuration and access management
Support safety database reconciliation activities.
3. Documentation & Safety Planning
Assist in preparation of:
Safety Management Plans (SMPs)
Reconciliation plans
Safety job aids, templates, and training materials
Support development of safety documentation for audits and inspections.
4. Reporting & Metrics
Support preparation of:
Monthly safety reports
Study status reports
Ensure accuracy and quality of safety metrics and data.
5. Systems & Functional Support
Assist with:
Safety system setup and maintenance
Access requests and training assignments
TMF (Trial Master File) documentation activities
6. Compliance & Quality Assurance
Ensure adherence to:
SOPs
Regulatory requirements (US & international)
Pharmacovigilance guidelines
Support audit readiness and documentation accuracy.
7. Communication & Collaboration
Work closely with Global Safety Leads.
Assist in preparing presentations and stakeholder communications.
Participate in internal and external meetings as required.
Required Qualifications
Education (Any ONE of the following)
Non-degree + 1 year safety experience OR 3 years relevant experience
Associate degree + 1 year safety experience OR 2 years relevant experience
Bachelor’s degree (Life Sciences or related) + 1 year relevant experience
Master’s degree + 1 year relevant experience
PharmD + 1 year relevant experience (residency/fellowship may count)
Experience
Experience in pharmacovigilance or clinical safety operations.
Exposure to adverse event processing or safety reporting systems preferred.
Skills & Knowledge
Strong attention to detail and accuracy.
Good written and verbal communication skills.
Ability to work independently with moderate supervision.
Strong teamwork and collaboration skills.
Basic proficiency in MS Office and Windows tools.
Ability to manage multiple tasks efficiently.
Preferred Skills
Experience in mentoring or peer support.
Understanding of safety reporting workflows and regulatory requirements.
Familiarity with clinical or pharmacovigilance systems.
Work Environment
Office-based or remote work setting.
Collaborative safety operations environment.
Inclusion & Accessibility
Fortrea is committed to equal opportunity employment and fostering an inclusive workplace.
Reasonable accommodations are available during the recruitment process upon request.
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Remote, India | Siliguri |Illinois :
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