**Main responsibilities:** + Manage the PV Configuration Standards, Distribution Rules, Study Configurations in LSMV, LSR & EV triage module + Perform User Accept Testing for Configuration Changes on behalf of the PV Systems Business Team + Work with Business Users to understand the Configuration changes and document them + Participate in updating training materials as releases move through the development and deployment process. Facilitate support and training sessions for system users + Support Safety Team during Audits & Inspections for providing Safety Data and Ad-hoc reports on urgency basis + Analyze the impact of changes to the system not just limited to Upgrades, Config Changes, Introduction of new features, and any other potential changes to the PV System + Implement relevant action items to mitigate any potential issues arising based on the Impact Analysis + Responsible for PV System Configurations of PV database- + Clinical & Post marketed Studies + ​Company Products + Business user Roles & Data Privacy + Code Lists, Libraries, MedDRA, WHO + Distribution Rules + Accounts & HA Destinations + E2B Profiles + SDEA profiles & gateway + Manage E2B gateway with Health authorities & Business Partners + Implement Data Migration & Ingestion requests + Actively participate and contribute to the growing needs of Drug Safety PV Regulations + Support digital vendor teams in Configuration Changes needs, Testing & Deployments + Work with Business Users to understand the Configuration change needs and document them + Work in an Agile environment **_About you_** **Experience** : + _Experience in PV Databases like ARGUS, Aris-G, VAULT Safety, LSMV etc._ + _Experience in a systems operations support role within safety/pharmacovigilance as configuration analyst, configuration manager_ + _Hands-on in Case Processing to support the Business User for troubleshooting and problem solving_ + _Experience in configuration of Products, INNs, Salts and their variations, MedDRA Events_ + _Hands-on experience in dealing with Local Affiliates and understanding their Regulatory needs_ + _Experience and understanding of the safety/pharmacovigilance process and regulations, ICH GVP and GxP regarding systems validation and documentation_ + _Knowledge of IT systems in the pharmaceutical industry with an emphasis on PV systems_ + _Knowledge of validation processes_ + _Good knowledge of SQL, PL/SQL and MS Office_ + _Minimum 5 years of pharmaceutical industry experience with a focus on pharmacovigilance_ + _Strong experience in Computer System Validation is required_ + _Incumbent should have hands-on in Process Improvement practices_ **Soft skills** : + _Stakeholder management, Strong negotiation and communication skills, and ability to operate effectively in a global environment and across-line functions._ + _Attention to details, Analytic, pro-active and effective problem-solving skills. Excellent organizational and project management abilities._ + _Strong communication and interpersonal skills. Ability to work effectively in a cross-functional, multicultural environment. Think strategically and lead teams._ + _Excellent team-work and interpersonal skills_ + _Ability to work in cross-functional teams_ + _Excellent oral and written communication skills_ + _Strong communication and interpersonal skills. Ability to work effectively in a cross-functional, multicultural environment. Think strategically and lead teams._ **Technical skills** : + _Regulatory Standards, Good Pharmacovigilance Practices (GxP), PV Configurations, Safety risk management, Safety Reporting Requirements._ + _Database Management: Familiarity with safety databases and systems (e.g., Aris-G / LSMV, Argus Safety, VigiBase, or similar systems) used for collecting, analyzing, and reporting adverse event data._ + _Software Testing/Validation: Knowledge of user acceptance testing (UAT) for pharmacovigilance software and familiarity with data migration processes during system upgrades_ + _Good depth understanding of Quality Risk Management and Quality systems_ **Education** : _Bachelor’s degree in pharmacy / Life Sciences / Engineering or equivalent Academic qualification is desirable with 5 years’ Technical Experience in GxP systems preferably in PV databases_ **Languages** : _Fluent in English (verbal and writt_ **Pursue** **_progress_** **, discover** **_extraordinary_** Better is out there. 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