Rupali Pokale

About Rupali Pokale

Pharmacovigilance Team Lead with 10+ years of experience in global drug safety operations. Proven expertise in team supervision, quality oversight, workload allocation, and audit preparedness. Strong ability to manage delivery timelines while mentoring team members and maintaining high compliance standards.

Experience

1. Lead Safety Science Specialist

   Fortrea

   Apr 2021 — Present · Pune District, IN

   Provide operational leadership for pharmacovigilance case processing activities, ensuring consistent quality, regulatory compliance, and on-time case submissions in line with SLAs.• Monitor quality metrics and perform error trend analysis to identify process gaps, implementing targeted corrective actions and training initiatives to improve overall case quality.• Act as a Subject Matter Expert (SME) for safety case processing, supporting team members with complex queries and ensuring adherence to client and regulatory requirements.• Deliver onboarding and process update training sessions to strengthen team competency and maintain alignment with evolving safety reporting requirements.• Collaborate with clients during quality discussions, contributing to issue resolution, process clarifications, and continuous improvement initiatives.• Support audit and inspection readiness by coordinating documentation, preparing the team, and representing operations during client audits or inspections.• Drive operational efficiency through proactive resource planning, workload distribution, and risk mitigation strategies.

Education

• All India Shivaji Memorial Societys College of Pharmacy, Pune

  Master's degree

  2013 — 2015

• Amravati University

  Bachelor of Pharmacy (B.Pharm.)

  2009 — 2012

Skills

• Public Speaking
• English
• Pharmaceutics
• Microsoft Word
• Powerpoint
• Research
• Formulation
• Teaching