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Senior Safety & Pharmacovigilance Specialist (Qc Experience)

Syneos Health
Syneos Health
6+ years
preferred by company
Gurugram, Hyderabad, India
1 May 18, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding

Senior Safety & Pharmacovigilance Specialist (QC Experience) – Drug Safety / Pharmacovigilance Jobs in Hyderabad | Syneos Health

Location: Hyderabad / 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 throughout the complete drug development and commercialization lifecycle. With strong expertise in pharmacovigilance, clinical research, regulatory operations, and patient safety, Syneos Health offers outstanding career opportunities for experienced drug safety professionals.

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


Job Overview

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

The selected candidate will be responsible for managing high-quality pharmacovigilance operations including case intake, triage, data entry, MedDRA coding, narrative review, duplicate management, literature surveillance, regulatory reporting support, xEVMPD activities, SPOR / IDMP support, and ICSR quality review.

This is an excellent opportunity for experienced drug safety professionals looking to work in a global CRO environment with leadership-level safety operations exposure.


Key Responsibilities

End-to-End Pharmacovigilance Case Processing

  • Manage Individual Case Safety Reports (ICSRs) from intake through final processing.
  • Perform case triage, validation, assessment, and workflow management as per SOPs and safety plans.
  • Review safety case data for completeness, consistency, and regulatory reporting eligibility.
  • Enter accurate pharmacovigilance data into validated safety databases.
  • Follow up on missing case information and ensure closure of outstanding queries.

ICSR Quality Review & Quality Control

  • Perform detailed Quality Check (QC) review of ICSRs and safety documentation.
  • Ensure compliance with pharmacovigilance quality standards, internal SOPs, and regulatory requirements.
  • Review case narratives, coding accuracy, regulatory completeness, and submission readiness.
  • Monitor and support quality metrics reporting and continuous process improvement.

Medical Coding & Safety Data Management

  • Perform MedDRA coding for adverse events, indications, medical history, and clinical findings.
  • Manage coding of concomitant medications and treatment-related safety information.
  • Support maintenance of drug dictionaries and product coding structures.
  • Perform manual recoding for unresolved product or substance terms.
  • Identify and manage duplicate safety cases.

Regulatory Safety Reporting

  • Support expedited safety reporting according to global regulatory timelines.
  • Assist with validation and submission of xEVMPD product records.
  • Support SPOR / IDMP compliance activities.
  • Apply updated pharmacovigilance regulatory intelligence to daily safety operations.

Literature Review & Complaint Handling

  • Conduct literature screening and review for safety-related adverse event identification.
  • Support device complaint and product quality complaint handling workflows.
  • Review safety signals and support regulatory safety documentation.

Clinical Trial & Post-Marketing Pharmacovigilance

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

Documentation, Audit & Compliance

  • Maintain documentation in:
    • Trial Master File (TMF)
    • Pharmacovigilance System Master File (PSMF)
  • Ensure compliance with:
    • GVP
    • ICH Guidelines
    • GCP
    • Global drug / biologic / device regulations
    • Internal SOPs and Work Instructions
  • Participate in audits, inspections, and compliance readiness initiatives.

Cross-Functional Collaboration

  • Work closely with pharmacovigilance teams, project stakeholders, sponsors, and quality teams.
  • Foster effective professional collaboration in global safety operations.

Required Qualifications

Educational Qualification (Mandatory)

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

Not Eligible

  • BSc
  • MSc