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Manager, Pharmacovigilance & Epi PVE Operations

Employer
Gilead Sciences, Inc.
Location
Foster City, CA, US
Start date
Oct 20, 2020

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Job Details

Manager, Pharmacovigilance & Epi PVE OperationsJapan - TokyoGilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.Making an impact on a global scaleInclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossibleSpecific Responsibilities:• Responsible for task management of junior employees performing operational job responsibilities that ensure compliance of pharmacovigilance activities including the collection, review, evaluation, processing, and submission of adverse event (AE) information received by Gilead PVE Responsible for internal and cross functional team representation and will lead cross functional work streams as required.• Addresses identified issues escalated to management and coordinates for resolution.• Provides on-the-job-training to on-site contract staff• Leads or actively participates in functional projects• May be responsible for performance management.• Manages routine and non-routine daily case management activities• Ensures team compliance with internal processes to meet all applicable internal/external reporting requirements for ICSR• Addresses/resolves issues/concerns in a timely manner.• Oversee all activities or responsibilities that are delegated to CRO and on-site contract staff and ensure quality and accuracy of deliverables• Oversees training and/or on-boarding activities• Leads and manages functional projects and work streams, taking responsibility for specific projects, with minimal direction from senior management• Leads cross-functional projects and serve as a point of contact to other functions in the organization and outside the organization.• Develops a process for quality review of data for the applicable functional area• Understands and manages the execution of PVE Business Continuity processes, as applicable• May be responsible for supervision and performance review.Knowledge, Experience & Skills:Essential:• 7+ Years of drug safety experience in both clinical and post-marketing environment with BA/ BS• 5+ Years of drug safety experience in both clinical and post-marketing environment with MA/ MS• Excellent written and oral communication/interpersonal skills both in Japanese and English.• Safety database and/or data entry experience required• Understanding of medical terminology and the ability to summarize medical information required• Knowledge and experience with safety reporting and regulatory compliance and experience with international safety reporting/regulations required• Ability to effectively represent Japan PVE Operations on multidisciplinary teams• The ability to provide direction to a team and to influence peers and team members appropriately• Ability to provide constructive feedback in a timely manner high-energy and fast paced environmentOther:• Eligible to work in Japan.If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community: https://gilead.avature.net/GileadAbout Gilead:Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.For Current Gilead Employees and Contractors:Please log onto your Internal Career Site to apply for this job.To apply, visit https://apptrkr.com/2026169Copyright ©2017 Jobelephant.com Inc. All rights reserved.https://www.jobelephant.com/jeid-4fa94e693d795a4bb37c6af42f69fad2

Company

Gilead Sciences is a biopharmaceutical company that discovers, develops, and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.
 

Company info
Website
Location
333 Lakeside Drive
Foster City
California
94404
United States

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