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