PV Specialist

Role & Responsibilities
• Collect, assess, and investigate adverse events, product malfunctions, and complaints related to medical devices
• Prepare and submit MDV reports to CDSCO, US FDA, and EU authorities
• Maintain documentation for recalls, FSCAs, risk assessments, and CAPA implementation
• Handle end-to-end complaints management and audit support
• Monitor and report ADRs from spontaneous reports, literature, and clinical trials
• Prepare and submit ICSRs, PSURs, and DSURs
• Perform signal detection, trend analysis, and risk–benefit assessments
• Execute Post-Marketing Surveillance (PMS) activities
• Ensure compliance with global PV and MV regulatory requirements

Qualification
• B.Pharm / M.Pharm

Experience
• 1–6 years in Pharmacovigilance or Medical Device Vigilance

Skills
• Strong knowledge of global PV and MDV regulations
• ICSR, PSUR, DSUR preparation
• Complaints handling and CAPA management
• Audit readiness and regulatory compliance
• Good communication and documentation skills

About the Company
Appasamy is a leading medical device and pharmaceutical organization known for its high-quality ophthalmic products and strong commitment to patient safety, regulatory compliance, and innovation in healthcare solutions.