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Senior Safety & Pharmacovigilance Specialist (Qc Experience)

Syneos Health
Syneos Health
6+ years
preferred by company
Gurugram, India
1 May 18, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: CPC Certified, Data Analysis, Document Management, Life Science, Regulatory Compliance, Waterfall Model, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Wat, GCP guidelines, gmp knowledge, HSE Knowledge , Logistics and Transportation Management, Master Data, Operational Excellence, Sap Erp, supply chain management, Supply Planning, Warehouse Management

Senior Safety & Pharmacovigilance Specialist (QC Experience) – Pharmacovigilance Jobs in Gurugram | Drug Safety Quality Control | Syneos Health

Location: Gurugram, India (Office-Based)
Company: Syneos Health
Job Type: Full-Time
Department: Pharmacovigilance / Drug Safety / Quality Control
Experience Required: Minimum 6+ years of Pharmacovigilance experience with 3+ years of Quality Check (QC) experience (Mandatory)
Job ID: 25107316
Joining Preference: Immediate / Early Joiners Preferred


About the Company

Syneos Health is a globally recognized biopharmaceutical solutions and clinical research organization supporting pharmaceutical, biotechnology, and healthcare innovators across the full drug development and commercialization lifecycle. With strong expertise in pharmacovigilance, clinical safety, regulatory operations, and global healthcare solutions, Syneos Health provides excellent career opportunities for experienced drug safety professionals.

This opportunity is ideal for professionals seeking advanced careers in pharmacovigilance, ICSR quality review, drug safety operations, medical coding, post-marketing surveillance, and regulatory safety compliance.


Job Overview

Syneos Health is hiring a Senior Safety & Pharmacovigilance Specialist (QC Experience) for its Gurugram office location. This role is designed for experienced pharmacovigilance professionals with proven expertise in end-to-end case processing, ICSR quality control, post-marketing safety, clinical trial pharmacovigilance, EDC systems, device complaint management, and global safety compliance.

The selected candidate will be responsible for high-quality safety case processing, regulatory safety support, pharmacovigilance quality checks, medical coding, safety reporting coordination, and compliance-driven pharmacovigilance operations.

This role is ideal for senior PV professionals looking to advance within global CRO drug safety operations.


Key Responsibilities

End-to-End ICSR Case Processing

  • Manage Individual Case Safety Reports (ICSRs) from case intake through completion.
  • Perform safety case triage, assessment, validation, and workflow management according to pharmacovigilance SOPs.
  • Review case data for completeness, consistency, medical relevance, and regulatory reportability.
  • Enter and maintain accurate data within validated pharmacovigilance safety databases.
  • Initiate and manage follow-up queries to ensure case completeness.

ICSR Quality Control & Quality Review

  • Perform Quality Check (QC) review of safety cases and pharmacovigilance documentation.
  • Review narrative quality, coding accuracy, regulatory completeness, and reporting readiness.
  • Ensure adherence to internal quality benchmarks and pharmacovigilance compliance standards.
  • Support tracking and monitoring of pharmacovigilance quality metrics.

Medical Coding & Safety Data Management

  • Perform MedDRA coding for adverse events, indications, medical history, and related clinical terms.
  • Code concomitant medications, laboratory findings, and treatment-related safety data.
  • Support drug dictionary maintenance and coding governance.
  • Perform manual recoding of unresolved product or substance information.
  • Detect and manage duplicate safety reports.

Regulatory Reporting & Compliance Support

  • Assist in expedited adverse event reporting in accordance with applicable global regulations.
  • Support xEVMPD validation and product record submissions.
  • Contribute to SPOR / IDMP regulatory compliance activities.
  • Apply updated regulatory intelligence to daily pharmacovigilance workflows.

Clinical Trial & Post-Marketing Safety Operations

  • Support both:
    • Post-marketing pharmacovigilance activities
    • Clinical trial safety operations
  • Work with Electronic Data Capture (EDC) systems where applicable.
  • Ensure compliance across clinical and commercial safety programs.

Literature Surveillance & Complaint Handling

  • Conduct literature screening and safety literature review.
  • Support device complaint and product quality complaint handling activities.
  • Review safety-related documentation for regulatory consistency.

Documentation, Compliance & Audit Readiness

  • Maintain safety documentation within:
    • Trial Master File (TMF)
    • Pharmacovigilance System Master File (PSMF)
  • Ensure compliance with:
    • Good Pharmacovigilance Practices (GVP)
    • Good Clinical Practice (GCP)
    • ICH Guidelines
    • Global regulatory standards
    • Internal SOPs and Work Instructions
  • Participate in audits, inspections, and quality improvement initiatives.

Cross-Functional Collaboration

  • Collaborate with pharmacovigilance teams, quality teams, sponsors, and project stakeholders.
  • Maintain effective professional communication across safety operations.

Required Qualifications

Educational Qualification (Mandatory)
Eligible candidates must hold one of the following degrees:

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

Not Eligible

  • BSc
  • MSc