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Pspm Support Associate | Clinical Safety & Pharmacovigilance Operations

Fortrea
Fortrea
1+ years
preferred by company
Bangalore, India
1 May 12, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

PSPM Support Associate | Clinical Safety & Pharmacovigilance Operations

Job Location: Bangalore, India
Job Type: Full-Time
Department: Clinical Safety / Pharmacovigilance / Drug Safety Operations
Work Mode: Office-Based / Remote / Hybrid (As per business requirements)
Experience Required: 1+ Years
Freshers Eligible: Limited (Only candidates meeting educational eligibility with relevant exposure may be considered)
Industry: Clinical Research / Pharmacovigilance / Pharmaceuticals / Life Sciences / Drug Safety

Job Overview

We are hiring a PSPM Support Associate for a clinical safety and pharmacovigilance operations role in Bangalore. This opportunity is ideal for professionals with experience in drug safety, adverse event processing, pharmacovigilance operations, clinical trial safety support, and post-marketing surveillance.

The selected candidate will support global and regional clinical safety projects, assist with adverse event case management, contribute to safety documentation, support regulatory compliance activities, and coordinate safety operations for pharmaceutical and clinical research programs.

This is an excellent opportunity for candidates seeking long-term careers in pharmacovigilance, drug safety operations, clinical safety management, and global healthcare research services.

Job Responsibilities

  • Support global and regional clinical safety and pharmacovigilance projects from study setup through project closure.
  • Assist with adverse event (AE) processing, safety data management, and case handling for clinical trials and post-marketing products.
  • Ensure safety cases are processed accurately and submitted within client and regulatory timelines.
  • Support preparation of Safety Management Plans (SMPs), reconciliation plans, and project-specific safety documentation.
  • Assist in creation of study-specific job aids, SOP guidance materials, templates, and training resources.
  • Support safety systems setup, maintenance, access management, and project workflow coordination.
  • Assist with safety database reconciliation and pharmacovigilance data consistency checks.
  • Prepare monthly safety reports, project metrics, dashboards, and performance documentation.
  • Support safety presentations for internal stakeholders, sponsors, and client teams.
  • Assist in Trial Master File (TMF) documentation management and audit readiness preparation.
  • Support preparation of documentation for internal audits, client inspections, and regulatory reviews.
  • Ensure compliance with global pharmacovigilance regulations, SOPs, safety reporting standards, and client requirements.
  • Maintain confidentiality, data quality, and healthcare compliance standards.
  • Demonstrate strong collaboration, accountability, and adherence to company quality processes.

Required Qualifications

Candidates should meet one of the following eligibility criteria:

  • Non-degree qualification + 1 year of pharmacovigilance/safety experience OR 3 years of relevant industry experience
  • Associate Degree + 1 year of safety experience OR 2 years of relevant professional experience
  • Bachelor’s Degree (BS/BA) + 1 year of relevant experience
  • Master’s Degree (MS/MA) + 1 year of relevant experience
  • PharmD + 1 year of relevant experience
  • PharmD residency or fellowship may be considered as relevant experience

Preferred Educational Background

Degrees in:

  • Pharmacy
  • Life Sciences
  • Biological Sciences
  • Nursing
  • Medical Sciences
  • Clinical Research
  • Healthcare-related disciplines

Experience Requirements

  • Minimum 1+ year of relevant experience in pharmacovigilance, drug safety, clinical safety, adverse event processing, or healthcare operations
  • Freshers are generally not eligible unless meeting alternative relevant experience pathways
  • Prior exposure to clinical safety reporting, case processing, or regulatory compliance workflows is preferred