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Safety & Pharmacovigilance Specialist I – Pharmacovigilance

Syneos Health
Syneos Health
0-2 years
preferred by company
Hyderabad
2 May 18, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing

Safety & Pharmacovigilance Specialist I – Pharmacovigilance Jobs in Hyderabad | Syneos Health

Location: Hyderabad, India
Company: Syneos Health
Job Type: Full-Time
Department: Pharmacovigilance / Clinical Safety / Drug Safety Operations
Experience Required: 0–2 years (Freshers with relevant academic background and pharmacovigilance knowledge can apply)
Job ID: 25107956


About the Company

Syneos Health is a globally renowned life sciences and biopharmaceutical solutions organization supporting pharmaceutical, biotechnology, and healthcare innovators throughout the drug development and commercialization lifecycle. The company is known for delivering advanced clinical development, regulatory, and pharmacovigilance solutions to global healthcare leaders.

This opportunity is ideal for candidates looking to establish a long-term career in pharmacovigilance, drug safety operations, adverse event case processing, regulatory reporting, and global clinical safety functions.


Job Overview

Syneos Health is hiring a Safety & Pharmacovigilance Specialist I for its Hyderabad location. This role is suited for freshers and professionals with up to 2 years of relevant experience in pharmacovigilance, drug safety, or clinical research.

The selected candidate will be responsible for handling pharmacovigilance operations including ICSR processing, MedDRA coding, adverse event review, literature screening, safety database management, expedited reporting, regulatory documentation, duplicate case handling, and quality review activities.

This is an excellent opportunity for life sciences and healthcare professionals seeking exposure to global pharmacovigilance systems and regulatory compliance frameworks.


Key Responsibilities

ICSR Processing & Safety Case Management

  • Process Individual Case Safety Reports (ICSRs) in compliance with pharmacovigilance SOPs and project-specific safety workflows.
  • Triage incoming adverse event reports and evaluate case completeness, medical accuracy, and regulatory reporting eligibility.
  • Accurately enter case details into validated pharmacovigilance safety databases.
  • Identify missing case information, initiate follow-up queries, and ensure proper resolution.
  • Maintain safety case tracking and workflow documentation.

Medical Coding & Data Management

  • Perform MedDRA coding for adverse events, indications, medical history, and clinical terms.
  • Code concomitant medications, laboratory findings, and treatment-related safety data.
  • Support drug dictionary maintenance and pharmacovigilance coding accuracy.
  • Perform manual recoding of unresolved product or substance terms.
  • Identify and reconcile duplicate ICSRs.

Narrative Writing & Regulatory Reporting

  • Draft complete, accurate, and medically structured case narratives.
  • Assist in expedited regulatory safety reporting as per applicable global compliance requirements.
  • Ensure timely, accurate, and quality-driven submission support.

Literature Surveillance & Pharmacovigilance Compliance

  • Conduct literature screening and medical literature review for safety signal detection and reportable adverse event identification.
  • Support xEVMPD validation and product record submission activities.
  • Assist with SPOR / IDMP regulatory data management tasks.
  • Apply updated regulatory intelligence in routine safety reporting functions.

Quality Assurance & Documentation

  • Perform quality review of ICSRs and associated pharmacovigilance documentation.
  • Maintain essential documentation in:
    • Trial Master File (TMF)
    • Pharmacovigilance System Master File (PSMF)
  • Ensure adherence to:
    • Good Pharmacovigilance Practices (GVP)
    • Good Clinical Practice (GCP)
    • ICH Guidelines
    • Internal SOPs and Work Instructions
    • Global drug, biologic, and medical device regulations

Cross-Functional Collaboration

  • Collaborate with internal pharmacovigilance teams, project stakeholders, and external partners.
  • Participate in audits, inspections, and process improvement initiatives.
  • Maintain professional working relationships within global safety operations teams.

Required Qualifications

  • Bachelor’s or Master’s degree in:
    • Pharmacy
    • Life Sciences
    • Biotechnology
    • Clinical Research
    • Nursing
    • Medicine
    • Allied healthcare disciplines
  • Basic understanding of:
    • Pharmacovigilance workflows
    • Adverse event reporting
    • ICSR lifecycle
    • Drug safety databases
    • Medical coding (MedDRA)
    • Regulatory compliance standards
  • Strong written communication and documentation skills
  • High attention to detail
  • Good analytical and organizational skills
  • Ability to work in a structured, deadline-driven environment