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Pharmacovigilance Specialist

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ICON
6+ years
Not Disclosed
Chennai, Trivandrum, India
2 May 7, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills:

Pharmacovigilance Specialist

Location: Chennai / Trivandrum, India
Work Mode: Remote or Office
Job Type: Full-Time
Experience Required: Minimum 6+ Years in Pharmacovigilance or Drug Safety
Industry: Pharmaceutical / Clinical Research / CRO


Job Overview

We are seeking an experienced and detail-oriented Pharmacovigilance Specialist to support global drug safety and patient safety operations. The selected candidate will be responsible for monitoring pharmaceutical product safety, analyzing adverse event data, conducting signal detection activities, and ensuring compliance with global pharmacovigilance regulations.

This role is ideal for professionals with expertise in pharmacovigilance, adverse event reporting, safety data analysis, regulatory compliance, and risk assessment within pharmaceutical, biotechnology, or CRO environments.


Key Responsibilities

Adverse Event & Drug Safety Management

  • Collect, review, analyze, and process:
    • Adverse Event (AE) reports
    • Serious Adverse Events (SAEs)
    • Drug safety cases
    • Patient safety data
  • Ensure timely and accurate safety reporting in compliance with:
    • Global pharmacovigilance regulations
    • Regulatory authority requirements
    • Internal SOPs

Signal Detection & Risk Assessment

  • Conduct:
    • Signal detection activities
    • Safety trend analysis
    • Risk assessments
    • Safety evaluations
  • Identify and evaluate potential product safety concerns and support appropriate mitigation actions.
  • Contribute to ongoing patient safety monitoring activities across clinical and post-marketing programs.

Regulatory Reporting & Compliance

  • Prepare and submit:
    • Safety reports
    • Regulatory submissions
    • Pharmacovigilance documentation
    • Drug safety records
  • Maintain compliance with:
    • ICH-GCP guidelines
    • Global pharmacovigilance standards
    • Industry best practices
    • Regulatory requirements

Cross-Functional Collaboration

  • Collaborate with:
    • Clinical Operations teams
    • Regulatory Affairs
    • Medical Safety teams
    • Data Management teams
    • Global project stakeholders
  • Support safety-related investigations and regulatory inquiries.
  • Contribute to process improvements and operational efficiency initiatives.

Pharmacovigilance Process Support

  • Stay updated on:
    • Drug safety regulations
    • Pharmacovigilance trends
    • Regulatory changes
    • Industry standards
  • Support continuous enhancement of pharmacovigilance systems and patient safety frameworks.

Required Qualifications

Educational Qualifications

Required Qualification:

  • Bachelor’s Degree in:
    • Pharmacy
    • Life Sciences
    • Nursing
    • Biotechnology
    • Healthcare
    • Or related scientific disciplines

Preferred Qualification

  • Advanced Degree preferred in:
    • Pharmacovigilance
    • Drug Safety
    • Clinical Research
    • Regulatory Affairs
    • Pharmaceutical Sciences