Pharmacovigilance Configuration Oversight Specialist

Job Description

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 the same Participate in updating training materials as releases move through the development and deployment process. Facilitate support and training sessions for system users Analyze the impact of changes to the system included but not just limited to Upgrades, Config Changes, Introduction of new features, and any other potential changes to the PV System Responsible for PV System Configurations of PV database- Company Products, Clinical & Post marketed Studies Business user Roles & Data Privacy Code Lists, Libraries, MedDRA, WHO Distribution Rules Accounts & HA Destinations E2B Profiles SDEA profiles & gateway Configure E2B gateway for Health authorities & Business Partners Perform Data Migration & Ingestion requests 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 This role will be one of the contact points for Business Users in CHC PV organization for all topics related to the Configurations of PV systems and databases, ensuring that the CHC PV needs are met This position requires multiple interfaces with partners and customers within and outside of the Company This role involves understanding the PV Configurations and ensuring that we follow PV Regulations Experience About you 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 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 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 Good knowledge of SQL, PL/SQL and MS Office Minimum 4 years of pharmaceutical industry experience with a focus on pharmacovigilance 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 minimum 4 years’ experience in GxP systems preferably in PV databases Languages : Fluent in English (verbal and written) Show more Show less