Tabhitha Kativarapu

About Tabhitha Kativarapu

Pharmacovigilance leader with 13+ years of experience across clinical and post-marketing…

Experience

1. Associate Manager

   Parexel

   Oct 2022 — Present · IN

   Leadership and Mentorship:Developed team members into Subject Matter Experts (SMEs)Provided mentoring, training, and coaching across the Pharmacovigilance GroupSupported team leads and members during challenging situationsInvested in team development and cross-node mentoringTechnical Expertise:Served as SME for all PV reporting processesProvided expert support on XEVMPD insertions, gateway set-ups, and regulatory submissionsDeveloped step-by-step procedures for MHRA ICSR portal, EMA & MHRA registration, EMA ICSR download, and FDA gateway submissionSupported new Health Canada gateway reporting and billing reports testingParticipated in Oracle Analytics Periodic reports testing and SOP reviewsOperational Excellence:Managed QC sign-off sheet compliance and leave trackerReviewed hours and studies allocationPerformed annual appraisals and provided promotion recommendationsIdentified and resolved employee issues impacting project performanceReviewed GPRG and Argus training programsPerform and support project and database transition activitiesCross-functional Support:Supported audits/inspections/bid-defense meetingsProvided SME support across the Safety groupStabilized and supported critical studies/projectsKey Achievements:Became the primary point of contact for questions relating to processes, guidelines, and technical support across the entire safety teamSuccessfully turned around numerous struggling studies, managing them effectively through to completionMaintained team stability during periods of resource scarcity by providing detailed guidance and supportSuccessfully managed and mitigated Quality Issues (QIs) across multiple projects

Skills

• Drug Safety
• Meddra
• Narrative Writing
• Clinical Trials
• Gcp
• Ich-Gcp
• Medical Writing
• Arisg
• Pharmacology
• Pharmacovigilance