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Senior Safety & Pharmacovigilance Specialist (Night Shift)

Syneos Health
Syneos Health
6+ years
preferred by company
Gurgaon, Hyderabad, Pune, India
1 May 13, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding

Job Title: Senior Safety & Pharmacovigilance Specialist (Night Shift)

Location: Hyderabad, Telangana, India (Office-Based)
Alternate Work Locations: Pune / Gurugram, India
Job Type: Full-Time
Experience Required: Minimum 6+ Years (Freshers are not eligible)
Industry: Pharmacovigilance / Drug Safety / Clinical Research / CRO / Pharmaceuticals / Biotechnology / Life Sciences
Department: Drug Safety / Pharmacovigilance Operations / Global Safety Surveillance

About the Role
We are seeking a highly experienced Senior Safety & Pharmacovigilance Specialist to support global pharmacovigilance operations, advanced ICSR case processing, quality review, regulatory safety reporting, and drug safety compliance within a global life sciences environment. This role is ideal for professionals with expertise in ICSR processing, pharmacovigilance quality control (QC), MedDRA coding, expedited reporting, xEVMPD compliance, SPOR/IDMP activities, and global safety operations.

The ideal candidate will play a critical role in end-to-end safety case handling, pharmacovigilance quality oversight, literature surveillance, TMF/PV documentation compliance, and regulatory reporting excellence.

This opportunity is highly suited for experienced pharmacovigilance professionals seeking senior global safety operations roles.

Key Responsibilities

End-to-End ICSR Case Processing

  • Perform end-to-end Individual Case Safety Report (ICSR) processing in alignment with global pharmacovigilance SOPs, project safety plans, and regulatory timelines.
  • Support intake, triage, evaluation, processing, documentation, and closure of adverse event cases.
  • Ensure all safety cases meet completeness, quality, and regulatory reporting standards.

Safety Case Triage & Clinical Data Evaluation

  • Review incoming safety reports for:
    • Completeness
    • Accuracy
    • Validity
    • Regulatory reportability
    • Follow-up requirements
    • Duplicate detection
  • Identify missing safety information and initiate appropriate follow-up queries until resolution.
  • Maintain high data quality standards across safety workflows.

Pharmacovigilance Quality Review (QC Mandatory)

  • Conduct quality control (QC) review of ICSRs to ensure accuracy, consistency, compliance, and reporting readiness.
  • Review case coding, narratives, medical data entry, case documentation, and regulatory classification.
  • Ensure quality standards align with global pharmacovigilance expectations and sponsor requirements.

Safety Database Management

  • Enter, maintain, and validate safety data in pharmacovigilance databases and internal tracking systems.
  • Ensure accurate data entry, audit trail integrity, and case lifecycle documentation.
  • Maintain operational visibility through safety tracking systems and quality dashboards where applicable.

Coding & Safety Terminology Management

  • Perform pharmacovigilance coding activities including:
    • Adverse event coding
    • Medical history coding
    • Concomitant medication coding
    • Laboratory/test coding
    • Product/substance coding
    • Drug dictionary maintenance
  • Apply global coding standards including MedDRA and relevant drug dictionaries.
  • Support manual recoding of unresolved product and substance terms from ICSRs.

Narrative Writing & Case Documentation

  • Prepare complete, accurate, and regulatory-compliant case narratives and safety summaries.
  • Ensure case documentation is medically coherent, traceable, and submission-ready.
  • Maintain high standards in pharmacovigilance documentation quality.

Expedited Reporting & Regulatory Safety Compliance

  • Support timely and accurate expedited safety reporting in accordance with global regulatory requirements.
  • Ensure compliance with reporting timelines, pharmacovigilance obligations, and internal safety governance.
  • Apply current regulatory intelligence to all assigned safety reporting activities.

Literature Surveillance & Signal Support

  • Perform literature screening and safety literature review to identify reportable adverse events and pharmacovigilance intelligence.
  • Support literature case processing and safety intelligence workflows.

xEVMPD / Product Compliance Activities

  • Support validation and submission of xEVMPD product records.
  • Ensure accurate MedDRA coding of indication terms and product-related regulatory information.
  • Support compliance with European medicinal product data governance requirements.

SPOR / IDMP Regulatory Data Support

  • Participate in structured medicinal product regulatory data activities including:
    • SPOR (Substance, Product, Organisation, Referentials)
    • IDMP (Identification of Medicinal Products)
  • Support product data quality and regulatory compliance initiatives.

Duplicate Case Management

  • Identify, assess, and manage duplicate ICSRs across safety systems.
  • Ensure case reconciliation accuracy and pharmacovigilance data consistency.

TMF / PV Documentation Compliance

  • Ensure submission of relevant documentation to:
    • Trial Master File (TMF) for clinical trial programs
    • Pharmacovigilance System Master File (PSMF) for post-marketing programs
  • Maintain documentation compliance per company SOPs and sponsor requirements.