Viswanath Akkula Email & Phone Number

- A diligent, self-motivated with a positive attitude, with over 12 years of Pharmacovigilance Team Management and Project Management experience, currently working as a Operations Manager at ProPharma Group.- Leading end-to-end PV projects in post-marketing and clinical trials for Drugs, Medical Devices and Biologics. - Experienced in Aggregate report generation and quality review of listings (PADER, PSUR, DSURs).- Experienced in data extraction, integration and homogenisation for Signal Management and Detection.- Pharmacovigilance Agreements (PVA), Safety Data Exchange Agreement (SDEA), knowledge of Pharmacovigilance System Master File (PSMF), and procedures development (RMP) relating to the PV System.- Project-related documentation for Audits and Audit participation.- Compliance with the client and global regulatory requirements.- Good knowledge of Good Clinical Practice (GCP) related to clinical safety documentation.- Worked on safety systems (ArisG 7.4.1, Argus Safety 8.1, 8.2.2), clinical systems (Medidata Rave) and document management systems (PTMF, eTMF, Veeva eTMF).- Worked on regulatory intelligence platforms like Tarius, Cortellis and regulatory websites.- Well-experienced in setting up/configuring Literature search strategies in EMBASE and PubMed. - Worked in the safety systems administration and testing environments.- Supported and Configured safety databases, and safety report distribution systems and performed Operational Qualification/Performance Qualification test scripts, in support of safety systems.- Contributed to the production of system-specific metrics and monitoring.- Power BI, OBIEE, SAP Business Objects, IBM Watson Analytics tool Handling

Listed skills include Clinical Trials, Pharmacovigilance, Drug Safety, Pharmacology, and 15 others.