Pratik Patil

About Pratik Patil

A highly accomplished and strategic Pharmacovigilance (PV) professional with over 8+ years of experience in global drug safety operations, quality assurance, and regulatory compliance. My expertise is anchored in leading complex Literature Surveillance projects and co-ordinating with Aggregate Reporting, where I serve as the principal owner of deliverables for Global, Local and MLM Standard Literature Reviews (SLRs) and assessment, ensuring strict adherence to international standards (ICH, GVP, GCP) and critical support for Risk management activities.As well I hold comprehensive, end-to-end PV expertise, ranging from hands-on ICSR case management, medical coding (MedDRA/WHO), and adverse event reporting, to developing and enforcing robust Quality Management System (QMS).What sets me apart is my focus on operational excellence: driving process improvement through Root causes Analysis (RCA) and CAPA, enhancing efficiency via PV database automation, and mentoring safety teams to maintain an audit ready system.I am actively seeking a SME/leadership role where I can leverage this unique blend of strategic foresight and operational depth to advance patient safety outcomes, ensure sustained regulatory excellence, and contribute to the growth and future-readiness of a world-class pharmacovigilance organization.

Experience

1. Senior Subject Matter Expert- Pharmacovigilance

   Cognizant

   Nov 2024 — Present · Pune, IN

   Project Assignment and Oversight: • Assigned and monitored project workloads. • Ensured quality of work and team efficiency aligned with contracted scopes and Safety Management Plans.• Literature Compliance and CAPA Management: • Ensured Literature screening compliance. • Managed CAPA and deviations. • Utilized internal literature databases for Quality Management System maintenance, including SOP definition, validation, and quality metrics reporting.• Regulatory Compliance Expertise: • Maintained and enforced adherence to SOPs, Work Instructions, global regulations, GCPs, ICH guidelines, GVP modules, and study plans within pharmacovigilance processes.• Training and Mentorship: • Identified training needs. • Prepared and delivered comprehensive training programs. • Mentored Safety team members to enhance their skills and ensure alignment with organizational standards.• Aggregate reporting relevance and signal detection relevance from various literature sources.Drafting the literature summaries for insertion in the sections of aggregate reports.• Audit and Inspection Readiness:Supported audit/inspection readiness activities by reviewing compliance documents, preparing training files, and acting as a subject matter expert during audits and interviews.

Education

• MITCON INSTITUTE OF MANAGEMENT

  Master of Business Administration

• Mitcon Institute of management, Pune

  PGDM, Pharmaceutical Management

  2013 — 2015

• Shivaji University

  Bachelor of Pharmacy (B.Pharm.), Pharmaceutical Science

  2009 — 2013

• Shivaji University

  Bachelor of Pharmacy