Medifodil Smart Pharma Solutions is a trusted partner in Pharmacovigilance and Regulatory services, dedicated to ensuring drug safety and compliance with global standards. We are committed to excellence, innovation, and delivering long-term value to our clients through high-quality, reliable, and timely solutions.

We are looking Pharmacovigilance professional with 10+ years’ experience to lead end-to-end PV operations. The ideal candidate will bring strong expertise in aggregate reporting, signal detection, and risk management, along with proven experience in client management, quotation preparation, market analysis, and business development.

~Key Responsibilities

Pharmacovigilance Operations

• Oversee case processing, end-to-end pharmacovigilance activities including ICSR case processing, narrative writing, expedited reporting, and aggregate reporting (PBRER, DSUR, PSUR).
• Lead signal detection, risk management, and safety database activities in line with global regulatory standards (ICH, EMA, FDA, CDSCO).
• Establish, review, and update SOPs and PV processes to drive operational excellence.

~Client & Business Management

• Prepare tailored quotations, proposals, and cost estimates to meet client requirements.
• Conduct market analysis to identify opportunities and improve competitiveness.
• Serve as the primary contact for client communications, audits, inspections, and escalations.
• Provide strategic inputs for service expansion and client acquisition.

~Quality & Compliance Oversight

• Ensure timely, high-quality PV deliverables and regulatory submissions.
• Review and approve aggregate safety reports for accuracy and compliance.
• Lead internal audits and ensure inspection readiness at all times.

~Team Leadership

• Supervise, mentor, and develop PV associates to achieve performance excellence.
• Manage resource allocation and resolve operational challenges effectively.
• Foster a culture of accountability, compliance, and continuous learning.

~Cross-Functional Collaboration

• Work closely with regulatory, medical writing, and clinical operations teams for seamless service delivery.
• Contribute to organizational growth, innovation, and strategic initiatives.