Ashok Reddy Email and Phone Number

I began my career on 14 Nov 2019 as a Jr. Drug Safety Associate at Qinecsa (formerly Bioclinica), supporting Merck Oncology Safety Services. Starting with data entry, I consistently delivered high-quality work, earning a promotion to Triage within 9 months. On 10 Jan 2021, I advanced to the role of QR, honing my expertise in regulatory compliance, quality reviews, and process efficiency. By 1 Jul 2021, I expanded my responsibilities as a Team Leader and Subject Matter Expert, providing guidance and driving process improvements. Key contributions during this tenure: - Processed diverse case types (solicited, clinical trial, spontaneous, literature) using ARISg, LSSMV, Oracle Argus Safety, and AgXchange (IRT). - Conducted adverse event coding (MedDRA), causality assessments, and safety narrative preparation. - Led CAPA (Corrective and Preventive Actions) and RCA (Root Cause Analysis) initiatives for quality enhancement. - Oversaw deviation management, risk assessments, and change controls using Trackwise Digital, Quadrant, and eQMS. - Coordinated audits, inspections, and cross-functional operations for regulatory compliance. In Aug 2023, I joined Vizen Life Sciences as a Drug Safety Associate-II, further refining my skills in: - Conducting initial case checks, database searches, and triage for global pharmacovigilance workflows. - Managing adverse event coding (MedDRA), seriousness assessments, and regulatory compliance. - Supporting global IRT workflows and communication cases with a focus on data confidentiality. Currently, I serve as a Business Process Lead at Tata Consultancy Services (since Dec 2023), specializing in: - Driving CAPA and deviation management to optimize processes and enhance compliance. - Managing audits, inspections, and risk assessments using Trackwise Digital, Quadrant, and eQMS. - Collaborating with cross-functional teams to ensure operational excellence and regulatory adherence. Technical Proficiencies:- Safety databases: ARISg, LSSMV, Oracle Argus Safety, AgXchange (IRT). - QMS tools: Trackwise Digital, Quadrant, eQMS. - Regulatory frameworks: GVP modules, FDA regulations, and ICH-GCP guidelines. With a PharmD degree (2019) and over 5 years of experience, I bring expertise in pharmacovigilance, regulatory compliance, and quality management, alongside a proven track record of leadership and process optimization.