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Country Safety Lead & PVOIC - India | Global Biotech | Remote

India Permanent Work from Home or Hybrid View Job Description
Own end-to-end pharmacovigilance operations in India, ensuring compliance with local and global safety requirements. Act as the primary PV leader and authority-facing expert while shaping safety strategy and maintaining inspection readiness.
  • Lead pharmacovigilance strategy & compliance in a critical market
  • Fully remote role with high visibility and global PV exposure

About Our Client

Our client is a leading global biotechnology organisation committed to advancing therapies for complex and rare diseases. With a strong science-driven approach, they focus on innovation, patient safety, and delivering high-impact treatments worldwide.

Job Description

  • Lead and manage all pharmacovigilance activities for India
  • Serve as the PVOIC and primary contact for regulatory authorities
  • Ensure compliant handling and reporting of ICSRs and aggregate reports
  • Establish and maintain local PV systems aligned with global frameworks
  • Drive inspection readiness and act as lead for audits and health authority inspections
  • Manage PV vendors and oversee outsourced operations
  • Develop and maintain SOPs, safety management plans, and compliance processes
  • Deliver PV training and support cross-functional safety initiatives
  • Contribute to global PV strategy and continuous improvement efforts

The Successful Applicant

A successful Country Safety Lead / PV Officer in Charge should have:

  • 8+ years of pharmacovigilance/drug safety experience
  • Strong knowledge of Good PV Practices and Indian regulatory requirements
  • Experience with audits, inspections, and regulatory interactions
  • Background as or eligibility for PVOIC/LQPPV role
  • Experience managing vendors and PV operations
  • Scientific degree (Pharmacy or Medicine)
  • Strong stakeholder management and communication skills
  • Ability to operate independently in a remote, matrixed setup

What's on Offer

  • Fully remote, high-impact individual contributor role
  • Opportunity to lead PV for a global, research-driven biotech organisation
  • Strong exposure to global safety strategy and leadership
  • Competitive compensation with long-term career progression



If you are excited to contribute to a key role in safety and compliance, we encourage you to apply for this opportunity.

Quote job ref
JN-062026-7035934

Job summary

Function
Healthcare & Life Sciences
Sub Sector
Regulatory Affairs
What is your area of specialisation?
Healthcare / Pharmaceutical
Location
India
Job Type
Permanent
Job Reference
JN-062026-7035934
Work from Home
Work from Home or Hybrid

Diversity & Inclusion at Michael Page

We don't just accept difference - we celebrate it. We encourage applicants from all backgrounds to apply for this role and are committed to building inclusive, diverse workplaces where everyone can thrive. If you require any support or reasonable adjustments during the recruitment process, please let us know.