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Lead Safety Science Specialist | Pharmacovigilance & Clinical Safety Operations

Fortrea
Fortrea
2-5 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

Lead Safety Science Specialist | Pharmacovigilance & Clinical Safety Operations

Job Location: Bangalore, India
Job Type: Full-Time
Department: Clinical Safety / Pharmacovigilance / Drug Safety
Work Mode: Office-Based
Experience Required: 2–5+ Years (Depending on educational background)
Freshers Eligible: No
Industry: Pharmaceuticals / Clinical Research / Pharmacovigilance / Drug Safety / Life Sciences

Job Overview

We are hiring a Lead Safety Science Specialist for a high-impact pharmacovigilance and clinical safety role in Bangalore. This opportunity is ideal for experienced professionals with expertise in adverse event case processing, serious adverse event reporting, pharmacovigilance compliance, aggregate safety reporting, signal detection, and global drug safety operations.

The selected candidate will be responsible for managing adverse event workflows, safety reporting submissions, regulatory compliance activities, safety database reconciliation, aggregate report preparation, and mentoring safety operations teams.

This is an excellent opportunity for professionals looking to advance their careers in clinical safety, pharmacovigilance, medical safety review, and global regulatory drug safety operations.

Key Responsibilities

  • Manage end-to-end adverse event (AE) and serious adverse event (SAE) case processing from receipt to submission.
  • Process safety data collected from clinical trials and post-marketing pharmacovigilance sources.
  • Perform:
    • Safety database entry
    • AE review and coding
    • Patient narrative writing
    • Follow-up for incomplete safety information
    • Label assessment for marketed products
  • Prepare and submit expedited SAE reports to:
    • Clients
    • Regulatory authorities
    • Ethics committees
    • Investigators
    • Third-party vendors
    • Internal project teams
  • Ensure compliance with global safety reporting timelines and project-specific reporting commitments.
  • Prepare and review critical pharmacovigilance documentation including:
    • ICSRs (Individual Case Safety Reports)
    • Annual IND Reports
    • DSUR (Development Safety Update Reports)
    • ASRs (Annual Safety Reports)
    • Periodic Reports
    • Safety line listings
    • Aggregate safety reports
  • Perform peer quality checks and independent QC reviews of safety reports.
  • Support signal detection, trend analysis, pattern recognition, and safety risk evaluation.
  • Coordinate safety database reconciliation with data management teams and clients.
  • Monitor study-level pharmacovigilance workflows to ensure compliance with delivery timelines.
  • Support development of:
    • Safety Management Plans (SMPs)
    • Reconciliation Plans
    • SOPs
    • Work Instructions
    • Safety documentation templates
  • Participate in project team meetings, client interactions, audit preparation, and inspection readiness activities.
  • Support cumulative safety data review for:
    • Drug Safety Monitoring Boards (DSMBs)
    • Regulatory agencies
    • Client reporting requirements
  • Support safety committee operations and endpoint committee coordination.
  • Train and mentor junior pharmacovigilance and safety team members.
  • Assist in proactive issue identification, quality improvements, and operational process optimization.

Required Qualifications

Candidates should meet one of the following educational and experience combinations:

  • Non-degree qualification + 2–3 years of safety experience OR 5 years of relevant experience
  • Associate Degree + 2–3 years of safety experience OR 4 years of relevant experience
  • Bachelor’s Degree (BS/BA) + 2 years of safety experience OR 3–4 years of relevant experience
  • Master’s Degree (MS/MA) + 2 years of safety experience OR 2–3 years of relevant experience
  • PharmD + 2 years of safety experience OR 2–3 years of relevant experience
  • PharmD residency/fellowship may count toward experience requirements

Preferred Educational Background

Degrees in:

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