Head Pharmacovigilance

Flamingo Pharmaceuticals

Navi Mumbai, Mumbai

On-site

INR 1,200,000 - 1,800,000

Full time

14 days+

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Job summary

Flamingo Pharmaceuticals seeks a Pharmacovigilance Lead to manage end-to-end PV activities ensuring global regulatory compliance. You will oversee ICSR case processing, including intake, data entry, medical review, causality assessment, and quality review submissions.

The role requires strong knowledge of ICH, GVP, FDA, EMA and MHRA PV requirements, plus excellent analytical and communication skills to support decision-making and safety risk assessments across products.

Qualifications

  • Strong knowledge of ICH, GVP, FDA, EMA and MHRA PV requirements.
  • Experience with PV databases and ICSR processing workflows.
  • Excellent analytical, communication, and decision-making skills.

Responsibilities

  • Lead end-to-end pharmacovigilance activities to ensure global regulatory compliance.
  • Oversee ICSR case processing: intake, data entry, medical review, causality assessment.
  • Ensure quality review and timely submission of PV reports.

Skills

ICH/GVP knowledge
Regulatory compliance
Data analysis
Medical review
Decision making

Tools

PV databases

Job description

Lead and manage the end-to-end Pharmacovigilance (PV) function, ensuring compliance with global regulatory requirements.

Oversee ICSR case processing, including intake, data entry, medical review, causality assessment, quality review submission.

Required Candidate profile
  • Strong knowledge of ICH, GVP, FDA, EMA and MHRA PV requirements.
  • Experience with PV databases such
  • Excellent analytical, communication and decision-making skills.
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