Director, Quality & Literature Management, Medical Safety Science - GILEAD (California)
For Current Gilead Employees and Contractors:
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Job Description
Specific Responsibilities:
• Oversees all operational and administrative aspects of the MSS-QLM
• Responsible for oversight of MSS-QLM functions including literature review for individual case safety reports (ICSRs), aggregate report quality check in collaboration with Risk Management (RM), Listedness/Expectedness activities in collaboration with RM, MSS-Coding Management team, and Medical Evaluation team (ME), medical review of ICSRs in collaboration with Medical Evaluation team, outsourcing and vendor management
• Develops projects and is accountable for the successful completion of all projects within the MSS-QLM team
• Influences strategic or corporate direction by participation in Management Leadership Team (MLT) in MSS and Extended Leadership Team (ELT) in PVE
• Recognized internally and externally as an expert in Drug Safety
• Recognized as a key representative within MSS functional area for quality and compliance
Essential Duties and Job Functions:
• Collaborates with ME, RM, MSS-Coding Management team, groups across PVE, GSI and outside vendors
• Demonstrates ability to establish and maintain productive collaborations with internal and external stakeholders/partners
• Demonstrates excellent leadership skills and effectiveness in motivation and delegation
• Demonstrates a high level of initiative and ability to work independently
• Works under consultative direction toward long-range goals and objectives; assignments are self -initiated with no direct supervision
• Manages performance, recruits, hires, develops and maintains key safety talent
• Leads/co-leads and/or participates in cross functional project teams
• Ensures that MSS-QLM fully and consistently supports goals of Research & Development (R&D)
Knowledge, Experience, and Skills:
• Requires a degree in health sciences (e.g. RN, BS, PhD, PharmD) or a relevant scientific discipline with 15 + years of experience, including 5 or more years in the biopharmaceutical industry
• Demonstrates excellent verbal and written communication and presentation skills
For jobs in the United States:
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For Current Gilead Employees and Contractors:
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