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Manager, Pharmacovigilance Database Support

Company: Bausch Health
Location: Bridgewater
Posted on: January 15, 2022

Job Description:

Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global company that develops, manufactures and markets a range of pharmaceutical, medical device and over-the-counter products, primarily in the therapeutic areas of eye health, gastroenterology and dermatology. We are delivering on our commitments as we build an innovative company dedicated to advancing global health. - Each day, Bausch Health products are used by over 150 million people around the world.Our approximately 21,000 employees are united around our mission of improving people's lives with our health care products, and we manufacture and market health care products directly or indirectly in approximately 100 countries. -Manager, Pharmacovigilance Database SupportUnder the supervision of the Application Administrator/Manager this position will assume responsibility for assisting in the maintenance of the Global Pharmacovigilance Safety System (database) including but not limited to: participating in User Acceptance Testing (UAT) Phase of new system implementations, system upgrades, data migrations, conduct safety system training, maintenance of Company Product Dictionary, distribution rules, safety system testing, and ensure the Global PV safety system management responsibilities and requirements are being met. - Provide guidance and assistance in the implementation and update of departmental procedural documents.Responsibilities:Support new system implementations, system upgrades, product divestures, data migrations, etc.Responsible for preparing UAT scripts, UAT Protocols, UAT Summary Reports for system upgrades and/or new system implementationsAssist in ARISg Database Training in database Validation and Production environments for new users, as applicableReview database vendor's Operational Qualification and Installation Qualification scripts, as applicableResponsible for Change control process of ARISg and Service Ticket Responsible for maintenance of the Company Product DictionaryResponsible for maintenance of Partner and Health Authority Distribution RulesMaster and maintain up-to-date knowledge of the US Federal Regulations and Guidelines governing the reporting of investigational and post marketing adverse events.Master and maintain knowledge of the ICH regulations and guidelines governing the global reporting of adverse events on investigational and/or marketed products (particularly ICH E2A, E2C and E2BQualifications:5-10 years industry experience including 5+ years of experience and understanding of Pharmacovigilance concepts and associated databases.Hands-on implementation experience with safety databases like ARISg or ARGUS.Experience in drug safety databases, including configuration and ongoing operational support.Solid understanding and application of guidelines detailed in 21 CFR Part 11, including system validation requirements.Familiarity with GCP, FDA, EMA pharmacovigilance regulatory requirements.Excellent written and oral communication skills to interact with internal and external stakeholders as needed.Strong knowledge of Drug Safety and Pharmacovigilance processes and regulations.Familiarity with Signal Detection tools Working knowledge of database design and system life-cycle conceptsPossesses good knowledge of Reporting ToolsProficiency with basic MS Office applications. Advanced Microsoft excel skill is preferredProject management and multitasking skills.Ability to work under pressure in order to meet tight deadlines. Ability to work well in a matrixed, global team environmentThis position may be available in the following location(s): US - Bridgewater, NJ
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.
To learn more please read -Bausch Health's Job Offer Fraud Statement.Requisition ID4982- -Posted09/30/2021-System & Database Standards-R&D-US - Bridgewater, NJ-City (1)US-NJ-Bridgewater

Keywords: Bausch Health, Trenton , Manager, Pharmacovigilance Database Support, Executive , Bridgewater, New Jersey

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