Roles & Responsibilities:
• Perform daily website review and pharmacovigilance compliance monitoring for Europe, UK, WHO, and ROW markets (India, Kazakhstan, South Africa, Ukraine, etc.).
• Identify safety-related updates and share with relevant stakeholders: ICSR updates with Case Processing team, PSUR updates with PSUR team, and signal-related updates with Signal Management team.
• Draft, review, and update SOPs in line with evolving global pharmacovigilance regulations.
• Coordinate with QPPV and Local Responsible Persons (LRPs) for regulatory queries and training activities.
• Archive emails and documents as per pharmacovigilance compliance requirements.
• Collect safety data from cross-functional teams for compliance report preparation.
• Prepare, review, and circulate compliance reports as per approved templates and SOPs.
• Conduct and support compliance meetings with QPPV, draft Minutes of Meeting (MoM), and track action items.
Qualification:
• M.Pharm in Pharmacology or Pharmaceutics.
Experience:
• 1–2 years of hands-on experience in Pharmacovigilance compliance, website review, and global regulatory reporting.
Skills:
• Strong knowledge of GVP Modules and global PV regulations (EU, UK, USFDA, India, MHRA, ROW).
• Hands-on understanding of PSMF, ICSR, PSUR, and RMP.
• Excellent written and verbal communication skills.
• Strong documentation, time management, and coordination abilities.
• Ability to work effectively in cross-functional pharmacovigilance teams.
About the Organization:
Macleods Pharmaceutical Ltd is a leading Indian pharmaceutical company with a strong global presence and a robust R&D focus. Known for its commitment to quality, compliance, and patient safety, Macleods operates across multiple regulated markets and offers professionals an opportunity to work on global pharmacovigilance systems in a dynamic and growth-oriented environment.
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