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Sr. Safety & Pv Specialist (Night Shift) – Pharmacovigilance & Drug Safety Operations

Syneos Health
Syneos Health
6+ years
preferred by company
Pune, India
1 May 12, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding

Sr. Safety & PV Specialist (Night Shift) – Pharmacovigilance & Drug Safety Operations

Company: Syneos Health
Job Title: Sr. Safety & PV Specialist (Night Shift)
Location: Pune, India
Work Model: Office-Based
Job ID: 25107397
Department: Clinical Solutions / Safety & Pharmacovigilance


About the Role

Syneos Health is hiring a Sr. Safety & PV Specialist (Night Shift) for its global Safety & Pharmacovigilance Operations team in Pune. This opportunity is ideal for experienced pharmacovigilance professionals with strong expertise in ICSR Case Processing, Quality Check (QC), Drug Safety Operations, MedDRA Coding, Regulatory Reporting, and Pharmacovigilance Compliance.

The selected candidate will manage end-to-end safety case processing, pharmacovigilance quality review, safety narrative writing, regulatory reporting support, and global drug safety compliance activities.

This role is best suited for candidates with minimum 6 years of Pharmacovigilance experience and mandatory expertise in ICSR processing and QC review.


Key Responsibilities

ICSR Processing & Drug Safety Operations

  • Process Individual Case Safety Reports (ICSRs) according to SOPs and project-specific safety plans
  • Perform case triage and evaluate safety cases for:
    • Completeness
    • Accuracy
    • Regulatory reportability
  • Enter and maintain safety data in pharmacovigilance databases
  • Track assigned safety operations and case processing activities

Medical Coding & Safety Review

  • Perform:
    • MedDRA coding
    • Drug coding
    • Medical history coding
    • Concomitant medication coding
    • Test result coding
  • Conduct literature screening and safety review activities
  • Maintain drug dictionary accuracy
  • Identify and manage duplicate ICSRs
  • Perform manual recoding of uncoded product and substance data

Narrative Writing & Query Management

  • Prepare complete and accurate safety narrative summaries
  • Identify missing case information requiring follow-up
  • Raise safety queries and ensure closure through follow-up activities
  • Maintain high standards of pharmacovigilance documentation quality

Regulatory Reporting & Compliance

  • Support preparation of expedited safety reports within required timelines
  • Assist with:
    • xEVMPD validation and submissions
    • SPOR / IDMP activities
    • Global regulatory reporting requirements
  • Ensure compliance with:
    • FDA safety regulations
    • ICH Guidelines
    • GCP
    • GVP
    • Global pharmacovigilance standards

Quality Review & Documentation Management

  • Perform mandatory Quality Check (QC) review of ICSRs
  • Support safety quality and compliance initiatives
  • Ensure relevant documentation is submitted to:
    • Trial Master File (TMF)
    • Pharmacovigilance System Master File
  • Support audit and inspection readiness activities

Cross-Functional Collaboration

  • Collaborate with:
    • Pharmacovigilance teams
    • Project stakeholders
    • Sponsors
    • Quality and regulatory teams
  • Participate in audits and operational discussions
  • Apply regulatory intelligence to safety reporting activities

Educational Qualification

Candidates must possess one of the following qualifications:

  • B.Pharm
  • M.Pharm
  • BDS
  • BMS
  • MBBS

Note: B.Sc / M.Sc candidates are not eligible.


Required Experience

Mandatory Experience

  • Minimum 6+ years of Pharmacovigilance experience
  • Strong ICSR Case Processing experience
  • Mandatory Quality Check (QC) experience

Preferred Experience Areas

  • Drug Safety Operations
  • Safety narrative writing
  • MedDRA coding
  • Literature screening
  • xEVMPD submissions
  • SPOR / IDMP activities
  • Safety database management