Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

Safety And Pv Ops Specialist Ii

Syneos Health
Syneos Health
2-5 years
Not Disclosed
Remote, India, India
1 May 8, 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, Medical Billing

Safety and PV Ops Specialist II
Location: India (Remote)
Company: Syneos Health
Job ID: 25106886
Job Type: Full-Time
Industry: Pharmacovigilance / Drug Safety / Quality & Compliance / Clinical Research


About the Company

Syneos Health is a globally recognized and fully integrated life sciences organization focused on accelerating customer success across clinical development, medical affairs, and commercialization. The company partners with pharmaceutical, biotechnology, and healthcare innovators to support safer, faster, and more efficient drug development worldwide.

With more than 25,000 professionals globally, Syneos Health combines scientific expertise, operational excellence, and patient-focused innovation to deliver advanced healthcare and pharmacovigilance solutions.


Job Overview

Syneos Health is hiring experienced professionals for the role of Safety and PV Ops Specialist II. The selected candidate will support pharmacovigilance operations, quality and compliance activities, training coordination, documentation management, and operational process improvement initiatives within the Safety & Pharmacovigilance business unit.

This remote opportunity is ideal for candidates with expertise in drug safety operations, quality systems, compliance management, training coordination, and pharmacovigilance process support within pharmaceutical, CRO, or healthcare environments.


Key Responsibilities

General Responsibilities

  • Maintain repositories of:
    • Training records
    • Safety & Pharmacovigilance finance documentation
    • Proposal tracking records
    • Audit and inspection logs
    • Departmental metrics and operational documents
  • Develop and maintain:
    • Job aids
    • Process documentation
    • Supporting operational records
  • Ensure compliance with:
    • SOPs
    • Policies
    • Safety Management Plans (SMPs)
  • Maintain knowledge of:
    • FDA guidelines
    • EU regulations
    • ICH Guidelines
    • Pharmacovigilance reporting requirements
  • Support operational and financial tracking activities for the Safety & Pharmacovigilance business unit
  • Assist with preparation of executive project review documentation and monthly finance meeting data
  • Generate and provide operational metrics and reports as required
  • Support additional business and operational activities assigned by management

Quality & Compliance Responsibilities

  • Support quality planning and controlled document management activities
  • Assist with development, revision, and review of departmental or client-specific documents
  • Track and communicate quality metrics and performance indicators
  • Support quality compliance verification and quality control processes
  • Identify and communicate operational risks through risk-based assessments
  • Participate in:
    • Corrective and Preventive Action (CAPA) activities
    • Root Cause Analysis (RCA)
    • Process improvement initiatives
  • Support evaluation, escalation, and resolution of pharmacovigilance quality issues
  • Collaborate with management and Corporate Quality Assurance teams
  • Support audit and inspection readiness activities for safety project teams
  • Assist with tracking and analysis of quality metrics within the PV business unit