Effective leadership and guidance to the team members, creates a positive and collaborative work environment, and ensures the Patient Safety & Pharmacovigilance mission of proactive, thorough, accurate, safety signal detection/MedDRA query management and compliance with regulatory requirements.Lead and guide a team of professionals who perform signal detection and MedDRA Query management activities. This involves establishing clear goals and outcomes, giving frequent feedback and… Show more Effective leadership and guidance to the team members, creates a positive and collaborative work environment, and ensures the Patient Safety & Pharmacovigilance mission of proactive, thorough, accurate, safety signal detection/MedDRA query management and compliance with regulatory requirements.Lead and guide a team of professionals who perform signal detection and MedDRA Query management activities. This involves establishing clear goals and outcomes, giving frequent feedback and coaching, handling work and resources, and promoting a constructive and cooperative work atmosphere.Setting performance targets, conducting performance evaluations, retain talents, and facilitating the professional development of team members. Identifying training and development needs, implementing strategies to enhance skills and competencies, and providing ongoing support and feedback to promote individual growth and team effectiveness.Ensuring compliance with pharmacovigilance regulations, guidelines, and company policies for automated signal detection activities and handling controlled terminologies/MedDRA Query management. Implementing quality control measures and participating in audits and inspections to ensure adherence to the required standards and identify opportunities for improvement.Provide leadership in implementing new tools, technologies, and methodologies to enhance signal detection, Controlled terminologies and MedDRA Query management and improve efficiency and accuracy. Show less

Supports the safety signal management by providing robust expertise on the correct use of MedDRA terminology/ search definitions to enable the identification of potential safety concerns which could impact clinical programs or marketed products.Manages and leads the development of standardized ADR definitions for all post marketing products across TAs which are essential for the correct use of increased frequency signal detection and auto-labelling.Serves as a primary contact for MedDRA… Show more Supports the safety signal management by providing robust expertise on the correct use of MedDRA terminology/ search definitions to enable the identification of potential safety concerns which could impact clinical programs or marketed products.Manages and leads the development of standardized ADR definitions for all post marketing products across TAs which are essential for the correct use of increased frequency signal detection and auto-labelling.Serves as a primary contact for MedDRA search definitions and guides stakeholders for the expert advice on MedDRA search strategies for any safety issues to be further investigated (dSPP, PSUR and RMP risk definitions).Provides guidance to safety physicians on the optimal use of MedDRA for safety risk definitions and on the consistent use of MedDRA query definitions across products, pre- and post marketing and throughout the product’s lifecycle.Acts as consultant when advice is required with respect to MedDRA mapping of SAE’s between Clinical and Safety databases.Acts as consultant to address queries such as regulatory requirements (GCP, GVP, etc.) with respect to MedDRA or MedDRA Licensing policy and/or data exchange with external partners or vendors and supports audits.Performs MedDRA update impact analysis during version release for centrally maintained safety data/Risk definitions and update the database as appropriate.Reviews Expedited rules, Critical events/Designated medical events (DME), important medical events (IME).Works closely with statistical programming/statisticians/Medical safety leaders to ensure the quality of MedDRA query definitions used in a search result for a product during analysis and submissions.Serve as a Novartis SME for MedDRA liaise with MSSO for change request in MedDRA dictionary/SMQ, Tests SMQs under development and provide feedback to CIOMS working group.Acts as a consultant for queries related to ontologies/Semantic frameworks to support integrative pharmacovigilance research Show less

SME-Clinical coding MedDRA, WHODDDictionary set up, administration/validation, Clinical coding review and approval, quality, Synonym list maintenance, ATC, SDG, SMQ support.coding specification script, end to end SET-UP of Coding tools-TMS, central Coding, Medidata RAVE, dsNavigator and CDMS/e-CRF platforms-Medidata RAVE, Inform, DataLabs and OC/OC-RDC. EDC optimisation, system transformation initiatives, ODM set up-coding tool validation, integration, algorithm specification… Show more SME-Clinical coding MedDRA, WHODDDictionary set up, administration/validation, Clinical coding review and approval, quality, Synonym list maintenance, ATC, SDG, SMQ support.coding specification script, end to end SET-UP of Coding tools-TMS, central Coding, Medidata RAVE, dsNavigator and CDMS/e-CRF platforms-Medidata RAVE, Inform, DataLabs and OC/OC-RDC. EDC optimisation, system transformation initiatives, ODM set up-coding tool validation, integration, algorithm specification development for automation systems supporting functional requirements. Data Management Support- coding edit check specification, data cleaning, data entry guidelines(CCG) data management plan, Database user acceptance test (UAT), Coding test scripts, PD/prohibited medication check list, discrepancy management, SAE reconciliation.Mentor-Global counterpart trainingsPlanning and execution-Training materials, coding convention-study specific/ Wide therapeutic areas, SOP, work procedure, operational activities, support HA questions- coded data retrieval strategies that support clinical safety analysis.Data standards- SDTM, conformance data specification, data/study migration support, industry standard documents review/revise. Show less

SME-Clinical coding MedDRA, WHODD Dictionary set up, administration/validation, Clinical coding review and approval, quality, Synonym list maintenance.coding specification script, end to end SET-UP of Coding tools-TMS, central Coding, Medidata RAVE, ds Navigator and CDMS/e-CRF platforms-Medidata RAVE, Inform, Data Labs and OC/OC-RDC.Data Management Support- coding edit check specification, data cleaning, data entry guidelines(CCG) data management plan, Database user acceptance test… Show more SME-Clinical coding MedDRA, WHODD Dictionary set up, administration/validation, Clinical coding review and approval, quality, Synonym list maintenance.coding specification script, end to end SET-UP of Coding tools-TMS, central Coding, Medidata RAVE, ds Navigator and CDMS/e-CRF platforms-Medidata RAVE, Inform, Data Labs and OC/OC-RDC.Data Management Support- coding edit check specification, data cleaning, data entry guidelines(CCG) data management plan, Database user acceptance test (UAT), Coding test scripts Show less

Clinical coding MedDRA, WHODD Dictionary set up, administration/validation, Clinical coding review and approval, quality, Synonym list maintenance.coding specification script, end to end SET-UP of Coding tools-ds Navigator Inform, OC/OC-RDC.EDC optimization, system transformation initiatives, ODM set up-coding tool validation, integration, algorithm specification development for automation systems supporting functional requirements.