CRQA is looking for Medical Device Pharmacovigilance - Materiovigilance SME - 3 to 4 months contractual position for global client. Hybrid - Mumbai base location. Please find below the details: The Medical Device Materivigilance SME will conduct a gap analysis of the Client’s pharmacovigilance (PV) processes, reviewing SOPs, manuals, and QMS against US, EMA, and India regulatory requirements. Based on findings, the SME will support remedial actions, including preparing SOPs and guidance documents for ICSR processing, periodic reporting, product complaint collection, and post-marketing surveillance (PMS). The SME will train the Client team and vendors on regulatory requirements, SOPs, and reporting processes. Responsibilities include quality review of ICSRs and periodic reports, QMS improvement, IT collaboration for ARGUS configuration, GDPR compliance in case processing, aggregate report preparation, and HHE for devices and combination products. Deliverables include a gap analysis report, updated SOPs, manuals, and compliance documents. This is a full-time, 3-4 month contract requiring 9-hour workdays, 5 days a week, with inspection-ready, QMS-compliant deliverables aligned with regulatory standards. Kindly share your updated CV with relevant experience on [email protected]