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    Senior Safety & Pharmacovigilance Specialist (Night Shift)

    Syneos Health
    Syneos Health
    4-8 years
    preferred by company
    Pune, India
    1 May 13, 2026
    Job Description
    Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Coaching Skills, Data Science, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Pro, Collaboration, Communication Skills, gmp, GMP Guidelines, Operational Excellence, Problem Solving Skills, Quality Agreements, Quality Compliance, Quality Management, Quality Standards, Regulatory Requ, Communication Skills, Continual Improvement Process, Master Data, Material Requirements Planning (Mrp), Materials Management, People Management, Production Planning, Supplier Relationship Management (Srm), Supply-Chain Man, CPC Certified

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

    Location: Pune, Maharashtra, India
    Job Type: Full-Time (Night Shift)
    Experience Required: 4–8 Years (Freshers are not eligible)
    Industry: Pharmacovigilance / Drug Safety / Clinical Research / CRO / Pharmaceuticals / Biotechnology / Life Sciences
    Department: Drug Safety / Pharmacovigilance Operations / Safety Surveillance

    About the Role
    We are seeking an experienced and detail-oriented Senior Safety & Pharmacovigilance Specialist to support end-to-end drug safety operations, ICSR processing, pharmacovigilance compliance, safety database management, and regulatory safety reporting within a global pharmacovigilance environment. This role is ideal for professionals with expertise in ICSR case processing, MedDRA coding, literature surveillance, expedited reporting, xEVMPD submissions, SPOR/IDMP compliance, and global pharmacovigilance operations.

    The ideal candidate will play a critical role in safety case management, regulatory compliance, case triage, coding, and pharmacovigilance operational excellence while supporting global drug safety programs in a night shift operational environment.

    This opportunity is highly suited for experienced pharmacovigilance professionals seeking growth in global safety operations and regulatory drug safety delivery.

    Key Responsibilities

    ICSR Processing & Case Management

    • Perform end-to-end Individual Case Safety Report (ICSR) processing in accordance with global pharmacovigilance SOPs, project safety plans, and regulatory timelines.
    • Review incoming safety cases for completeness, quality, and reportability requirements.
    • Support accurate intake, case documentation, processing workflows, and lifecycle case management.
    • Ensure timely handling of adverse event reports in compliance with global pharmacovigilance standards.

    Safety Case Triage & Data Review

    • Triage incoming ICSRs and assess case data for:
      • Completeness
      • Accuracy
      • Regulatory reportability
      • Duplicate detection
      • Follow-up requirements
    • Identify missing information and initiate case queries for clarification and completion.
    • Follow up with stakeholders until safety data is appropriately resolved.

    Safety Database Management

    • Enter and maintain pharmacovigilance case information within global safety databases and tracking systems.
    • Ensure high standards of data quality, consistency, and pharmacovigilance documentation accuracy.
    • Maintain audit-ready case records and operational tracking logs.

    Coding & Safety Data Standardization

    • Perform coding activities including:
      • Adverse event coding
      • Medical history coding
      • Concomitant medication coding
      • Test / laboratory coding
      • Product coding
      • Substance term reconciliation
    • Apply standardized coding dictionaries including:
      • MedDRA
      • Drug dictionaries
      • Product coding frameworks
    • Support manual recoding of unresolved product and substance terms where required.

    Narrative Writing & Safety Documentation

    • Prepare complete, medically accurate safety case narratives and case summaries.
    • Ensure safety documentation quality aligns with project expectations and regulatory reporting standards.
    • Maintain consistency in safety case documentation and narrative completeness.

    Expedited Reporting & Regulatory Safety Compliance

    • Support generation of timely, accurate, and compliant expedited safety reports in accordance with applicable global regulatory requirements.
    • Ensure adherence to pharmacovigilance reporting timelines and internal compliance standards.
    • Support regulatory submission readiness across assigned programs.

    Literature Surveillance & Safety Intelligence

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

    xEVMPD / Product Data Compliance

    • Support validation and submission of xEVMPD product records.
    • Ensure accurate coding of indication terms using MedDRA and applicable regulatory product data standards.
    • Maintain compliance with European pharmacovigilance product data requirements.

    SPOR / IDMP Regulatory Support

    • Support activities related to:
      • SPOR (Substance, Product, Organisation, Referentials)
      • IDMP (Identification of Medicinal Products)
    • Assist with structured medicinal product data governance and regulatory data quality activities.

    Duplicate Management & Case Quality Review

    • Identify duplicate ICSRs and manage reconciliation workflows appropriately.
    • Ensure case de-duplication accuracy and data consistency across safety systems.

    Operational Compliance & Quality Management

    • Maintain pharmacovigilance compliance with internal SOPs, regulatory frameworks, project-specific safety plans, and audit readiness expectations.
    • Contribute to operational quality excellence and continuous process improvement initiatives.

     

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