Bikash Satpathy Email & Phone Number

India

• Responsible for creating and validating ad hoc reports and queries needed to support Pharmacovigilance and signal detection activities as well and the review of these reports and queries to verify that they are accurate and consistent with the request from the subject matter expert• My role encompasses many of the operational aspects within the project unit. This role works directly with all GPV stakeholders, including DSOs, PV Scientists, to accurately interpret and translate business needs into the appropriate technical language to ensure that configuration, operations, validation, and/or analytic reporting deliverables meet business needs. This role is responsible for the oversight and management of various aspects of the safety database system as well as direct involvement and oversight of projects designed to deliver enhancements, change controls and future tools to support PV activities. • Additionally, I have oversight for multiple vendor activities supporting the team. The incumbent works with all Safety System and Data Management stakeholders to ensure accurate planning and execution of critical database system activities • Also participate in the configuration of the safety database as well as the development, validation and maintenance of the system enhancements including the generation and approval of documentation to support the customer methodology . I have a strong PV knowledge and working relationships with the user community as well as the Information Technology department.

Dordrecht, South Holland, Netherlands

• Work with business development, product development and commercial team on Literature service product portfolio, to provide technical service and consultation before ,during and after point of sale and ensure customer satisfaction.• Good exposure to literature search for pharmacovigilance and Literature search platform and databases like Ovid,Embase,Medline.• Gather ,understand and translate ,interpret and assess impact of new customer requirements and sales proposal for IT development and customer onboarding.• Keep track , manage of all upcoming and ongoing projects, perform prioritization ,lead discussion for technical solution • Provide technical support ,consultation to customers, product development and sales teams and to support pre-sales and post-sales processes• Understand a complex software product that delivers pharmacological data and address all product-related queries on time• Address quality-related queries around Software Validation and regulatory compliance of IT systems for Pharmacovigilance• Provide audit support, keep an eye on all the deviation to the process and system and address them via appropriate CAPA.• Contribute in RFI,RPF, new proposal, contract renewal, product development discussion and manage product portfolio.• Act as a bridge between product development and sales teams aligning product roadmap with strategic sales plans• Provide product team with customers’ feedback to help identify potential new features or products. Also to bring in improvement in product and reduce support costs.• Provide product support and training for customers together with the product development and sales teams• Provide support during audits by based on contractual agreements on products, services, quality, Software Validation and regulatory compliance• Monitor and report on product performance

Amsterdam Area, Netherlands

I have been associated with Tata Consultancy Services for the last 7 years with a total of 7 years of work experience. • I have sound domain knowledge in the area of Pharmacovigilance as I have been into the Healthcare and Life Science domain from the start my carrier.• Good knowledge of Pharmaceutical Safety Systems which includes E2B Regulations (EMEA/FDA/MHLW etc), ICSR’s, Safety Applications .• Proficient in widely used Oracle Argus Safety application which is a special pharmaceutical software tool used in the healthcare and life science industries for reporting and managing adverse events.• Having knowledge on EDI gateway namely Synchrony.• Configuring, implementing, maintaining and upgrading Safety system application modules.• Technological proficiency in SQL, PL/SQL using TOAD and have a good command over the query language of Oracle.• I have ability to handle multiple responsibilities simultaneously.• Currently leading the offshore team for Argus application support.• Well-versed with computer system validation and GxP guideline. • Experienced with Client ,vendor ,Business partner co-ordination and manage Projects. • Also have exposure to CTMS(clinical trial management system) tool like Impact apart from Trackwise and reporting tools like Cognos BI.

Leiden, South Holland, Netherlands

• Planning of team capacity, monthly planning for case processing team, KPI, managing the daily Tier process, Keep action logs for team, ensure escalation of issue/tasks to help PV team.• Responsible for issue handling and resolution on Argus & PV query tool• Escalation in case no timely resolution is found• Coordinate between Technical team and PV team.• Propose and take lead in improvement in work process.• Ensure compliance of the system and work processes, which means use change control for changes, ensure deviation and CAPAs are immediately created if applicable, and closed as agreed upon. • Gateway & E2B destination configurations• Generate reports and address safety database issues during Audit and inspection .• Take care of for tasks like create line listing ,Tenant configuration, Argus configuration, Manage submissions EMA & FDA, MedDRA upgrade & streamline monthly reconciliation of cases (incl literature searches). Also prepare monthly reports to measure and monitor KPI.• Prepare business cases for new project such as Argus upgrade, review vendor contracts ,maintain contact to look for new commercial opportunities

Executive Mba

Executive Mba, Business, Management, Marketing, And Related Support Services

Engineer'S Degree, Biotechnology, A

Education record