Pharmacovigilance Executive

3 weeks ago

Vadodara, India Shaily Engineering Plastics Full time

Role & responsibilities

  • Manage pharmacovigilance activities including adverse event reporting and vigilance documentation.
  • Ensure compliance with USFDA, EU MDR, ISO 13485 and global regulatory requirements
  • Prepare pharmacovigilance data, safety reports, and regulatory submissions/dossiers
  • Conduct post market surveillance, risk assessments and trend analysis
  • Handle product recalls, field corrective actions, and regulator communications
  • Support product registrations, renewal and audits across global markets
  • Liase with cross functional teams (R&D, Quality, Manufacturing) for compliance.

Preferred candidate profile

Strong knowledge of pharmacovigilance reporting systems, dossier filing and regulatory submissions.

Strong Analytical, documentation and communication skills.

Regulatory compliance mindset

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