Vaibhavi Mali

Operations Specialist 1 @IQVIA

Thane, IN

Complete assigned training on time and ensure compliance with all required SOPs and customer guidelines. •Process safety data per regulations, SOPs, and project requirements. •Perform pharmacovigilance activities, including- Collecting and tracking AE/endpoint information- Determining initial/update status of events- Database entry and coding AE/products- Writing narratives and literature-related activities. •Ensure adherence to quality, productivity, and delivery standards. •Create, maintain, and track cases per project plan. •Identify and report quality issues to senior team members. •Demonstrate problem-solving skills. •Liaise with internal teams (e.g, project management, clinical, data management) and external stakeholders (e.g, investigators, medical monitors, site coordinators). •Communicate with clients on case processing activities when required. •Mentor new team members if assigned by the manager. •Attend team meetings and provide feedback on challenges and successes. •Lead or support department initiatives. •Maintain 100% compliance with people practices and processes. •Depending on project requirements, perform medical review of non-serious AEs/ADRs, ensuring accuracy and completeness of medical information, AE coding, causality assessment, and documentation. Communicate necessary corrections to team leads. •Perform other assigned duties.

Marathwada Mitra Mandal's college of pharmacy

Bachelor's degree

Mumbai Educational Trust, MET League of Colleges

Master of Pharmacy