Anil Kumar Adapa

Quality Specialist Pharmacovigilance @Viatris

Spearheading the management of Corrective and Preventive Actions (CAPA) and deviations, ensuring swift and precise resolution to maintain the highest quality standards. Conducting retrospective Quality checks on Individual Case Safety Reports (ICSR) from vendors, assuring adherence to rigorous compliance benchmarks. Pioneering advancements in ICSRs quality through ingenious suggestions, devising improvement measures for the retrospective Quality Control process, effectively mitigating errors and proactively addressing emerging trends. Orchestrating seamless harmonization, consistently reconciling vendors\' training materials and Standard Operating Procedures (SOPs)/Work Instructions (WIs) on a quarterly basis, instilling coherence and unifying best practices. Actively participating in the implementation of internal quality enhancement initiatives, expertly assessing the efficacy of these measures, fostering an environment of continuous improvement. Demonstrating analytical acumen, meticulously scrutinizing the reverberating effects of business changes and Pharmacovigilance (PV) legislations on ARGUS Manual Chapters, proffering strategic insights for adaptability. Cultivating a culture of shared knowledge, proactively engaging in promoting individual and group learning, fostering heightened awareness of transformative developments within the esteemed Global PV Operations team. Conducting impactful training sessions within the sphere of Subject Matter Expertise (SME), empowering team members with cutting- edge acumen and competence in the impacted areas. Playing a pivotal role in the process optimization journey, actively engaging in the automation of Quality Control and Data Entry (DE) for Health Authority (HA) cases, amplifying efficiency and resource optimization.