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Safety & Pv Ops Specialist Ii – Pharmacovigilance Operations, Quality & Compliance

Syneos Health
Syneos Health
3+ years
preferred by company
Remote, India, India
1 May 12, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing

Safety & PV Ops Specialist II – Pharmacovigilance Operations, Quality & Compliance

Company: Syneos Health
Job Title: Safety & PV Ops Specialist II
Location: Remote – India
Job ID: 25106886
Department: Clinical Solutions / Safety & Pharmacovigilance


About the Role

Syneos Health is hiring a Safety & PV Ops Specialist II for its global Safety & Pharmacovigilance Operations team. This remote opportunity is ideal for professionals experienced in Pharmacovigilance Operations, Drug Safety, Quality Compliance, Safety Systems Management, Technical Writing, and Regulatory Reporting Support.

The selected candidate will support quality compliance initiatives, training programs, safety database operations, proposal development, audit readiness, and pharmacovigilance operational excellence across global projects.

This opportunity is best suited for candidates with 3+ years of Pharmacovigilance experience and strong expertise in technical documentation and PV operational support.


Key Responsibilities

Pharmacovigilance Operations Support

  • Maintain repositories for:
    • Safety project documentation
    • Training records
    • Audit and inspection documentation
    • Project finance records
    • Proposal tracking and RFI libraries
    • Departmental metrics
  • Develop and maintain:
    • Job aids
    • Process documentation
    • Supporting operational documentation
  • Ensure adherence to:
    • SOPs
    • Company policies
    • Safety management procedures
  • Support project teams with operational documentation and reporting activities

Quality & Compliance Management

  • Support:
    • Quality planning activities
    • Controlled document development and revision
    • Quality compliance verification
    • Quality control support
  • Assist in:
    • Risk-based process assessments
    • CAPA tracking and completion
    • Root cause analysis
    • Quality improvement initiatives
  • Identify and communicate:
    • Process deviations
    • Compliance risks
    • Quality deficiencies
  • Support audit and inspection readiness across safety projects

Training & Learning Management

  • Create, manage, and present training materials for Pharmacovigilance teams
  • Collaborate with leadership to develop updated training content
  • Support onboarding and role-based training initiatives
  • Manage Learning Management System (LMS) support activities
  • Track planned and ad hoc departmental training programs

Safety Database & Technology Support

  • Assist with management and maintenance of safety systems including:
    • User setup and access management
    • Project-specific safety database configurations
    • Safety database updates and patch management
    • MedDRA updates
    • WHO drug dictionary maintenance
    • Performance qualification (PQ) scripts
    • Safety reporting system compliance checks
  • Support:
    • SharePoint and other pharmacovigilance applications
    • Safety database issue resolution
    • Data migration validation
    • Internal and client safety reporting requests
    • Safety data query generation

Proposal & Business Operations Support

  • Assist in:
    • Request for Proposal (RFP) responses
    • Request for Information (RFI) support
    • Budget preparation
    • Proposal strategy development
    • Scope of work documentation
    • Change order support
  • Maintain proposal templates, costing models, and operational documentation
  • Support revenue forecasting and business operational metrics

Regulatory & Compliance Knowledge

  • Maintain knowledge of:
    • FDA Guidelines
    • EU Pharmacovigilance Regulations
    • ICH Guidelines
    • Global safety reporting requirements
  • Ensure operational compliance with internal and regulatory expectations

Educational Qualification

Candidates with backgrounds in the following areas are preferred:

  • Pharmacy
  • Life Sciences
  • Clinical Research
  • Healthcare
  • Pharmacovigilance
  • Related scientific disciplines

Required Experience

Mandatory Experience

  • Minimum 3+ years of Pharmacovigilance experience

Preferred Experience Areas

  • PV Operations
  • Drug Safety Operations
  • Safety Database Management
  • Quality Compliance
  • CAPA Management
  • Audit Readiness
  • Technical Documentation
  • Safety Reporting Support