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Safety & Pharmacovigilance Operations Specialist Ii

Syneos Health
Syneos Health
4-7 years
preferred by company
Remote
1 May 13, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding

Job Title: Safety & Pharmacovigilance Operations Specialist II

Location: India (Remote)
Job Type: Full-Time
Experience Required: 4–7 Years (Freshers are not eligible)
Industry: Pharmacovigilance / Drug Safety / Clinical Research / CRO / Pharmaceuticals / Biotechnology / Life Sciences
Department: Safety & Pharmacovigilance Operations / Quality & Compliance / Drug Safety Governance

About the Role
We are seeking a highly organized and quality-focused Safety & Pharmacovigilance Operations Specialist II to support pharmacovigilance operations governance, quality compliance, training management, process excellence, metrics reporting, and audit readiness across global safety programs. This role is ideal for professionals with expertise in pharmacovigilance operations, quality systems, CAPA management, SOP governance, audit readiness, training coordination, compliance monitoring, and PV business operations support.

The ideal candidate will serve as a key operational contributor supporting quality management, documentation governance, business operations reporting, training administration, and process improvement initiatives within a global pharmacovigilance function.

This opportunity is highly suited for experienced pharmacovigilance operations professionals seeking strategic non-case processing roles in global drug safety environments.

Key Responsibilities

Pharmacovigilance Operations Governance & Business Support

  • Support day-to-day operational governance activities across the Safety & Pharmacovigilance Business Unit (BU).
  • Maintain centralized repositories for operational and governance documentation including:
    • Training records
    • Safety & Pharmacovigilance finance documentation
    • Proposal tracking (awards/losses)
    • RFI libraries
    • Department metrics
    • Audit / inspection logs
    • Operational governance documentation
  • Ensure organized, accurate, and audit-ready documentation management.

Quality Compliance & SOP Governance

  • Ensure compliance with:
    • Standard Operating Procedures (SOPs)
    • Corporate policies
    • Safety Management Plans (SMPs)
    • Internal quality governance standards
  • Support controlled document lifecycle activities including creation, revision, review, and documentation governance.
  • Maintain process documentation, job aids, and supporting operational records.

Quality Planning & Compliance Monitoring

  • Support Quality Planning initiatives by assisting with department and client-specific documentation development.
  • Track quality deliverables and support governance frameworks that ensure operational consistency.
  • Contribute to compliance monitoring activities across pharmacovigilance operational programs.

Quality Assurance, Risk Management & CAPA Support

  • Support Quality Assurance and Quality Compliance activities by identifying risks, deviations, and operational gaps.
  • Participate in risk-based process assessments and compliance monitoring initiatives.
  • Assist with:
    • CAPA development
    • CAPA tracking
    • CAPA closure support
    • Root cause analysis participation
    • Quality issue escalation
  • Collaborate with leadership and Corporate Quality teams to resolve open quality issues effectively.

Audit & Inspection Readiness

  • Support global pharmacovigilance teams in maintaining continuous audit and inspection readiness.
  • Maintain audit documentation and inspection support records.
  • Track quality observations, remediation activities, and compliance follow-up actions.

Quality Metrics & Operational Reporting

  • Track, analyze, and report operational quality metrics for the Safety & Pharmacovigilance Business Unit.
  • Support performance dashboards, compliance trend analysis, and quality reporting reviews.
  • Deliver agreed metrics at defined reporting intervals.

Training Management & Learning Support

  • Create, maintain, track, and present pharmacovigilance training materials for planned and ad hoc learning initiatives.
  • Collaborate with senior pharmacovigilance leadership to identify training content needs.
  • Support training initiatives including:
    • Safety Specialist onboarding
    • Safety Coordinator training
    • Forecasting / finance awareness training
    • Process compliance education
    • Quality improvement learning initiatives
  • Maintain training records and compliance documentation.

Learning Management System (LMS) Administration

  • Provide operational support for Learning Management Systems (LMS) within the pharmacovigilance function.
  • Track learning completion, assignment status, training compliance, and reporting metrics.
  • Support training governance and audit readiness documentation.

Business Operations & Financial Coordination

  • Support annual revenue target processes by collaborating with operational leadership and project management teams.
  • Assist with business unit revenue recognition support and finance-related operational reporting.
  • Prepare information for:
    • Executive Project Reviews
    • Monthly Pharmacovigilance finance meetings
    • Operational business governance reviews

Regulatory Compliance Knowledge Support

  • Maintain working knowledge of applicable global regulatory frameworks including:
    • FDA pharmacovigilance regulations
    • EU pharmacovigilance requirements
    • ICH guidelines
    • Drug safety compliance expectations
  • Apply compliance awareness across assigned operational responsibilities.

Cross-Functional Collaboration

  • Work closely with:
    • Safety project teams
    • Quality & Compliance teams
    • PV operational leadership
    • Project Managers / Project Directors
    • Corporate Quality teams
    • Training stakeholders
  • Support collaborative execution of governance, compliance, and business operations activities.

Required Qualifications

  • Bachelor’s or Master’s degree in:
    • Pharmacy
    • Life Sciences
    • Biotechnology
    • Clinical Research
    • Biomedical Sciences
    • Healthcare-related disciplines
  • Minimum 4–7 years of relevant experience in pharmacovigilance operations, PV quality, compliance, governance, or drug safety operational support roles.
  • Strong expertise in:
    • SOP governance
    • Quality compliance
    • CAPA management support
    • Audit readiness
    • Quality metrics reporting
    • Documentation governance
    • Training coordination
  • Working knowledge of FDA, EU, and ICH pharmacovigilance regulations.
  • Experience with LMS systems, quality documentation, and process governance preferred.
  • Strong organizational, analytical, and communication skills.
  • Ability to work independently in remote environments.