Manager, Global Patient Safety Operations

Job Family: GLPS Operations is responsible for managing all operational aspects of Individual Case Safety Reports (ICSRs) to ensure compliance with applicable reporting requirements and supports Gilead clinical study activities and aggregate report submissions.

Job Overview/Summary:

• 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 GLPS 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

• Oversees training of junior staff

• Leads or actively participates in functional projects

• May be responsible for performance management

Job Responsibilities:

• 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 junior staff members 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 GLPS Business Continuity processes, as applicable

• May be responsible for supervision and performance review

Knowledge & Skills:

• Excellent interpersonal and communication skills, both written and oral

• 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 PV 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 environment

Education & Experience:

Exempt Professional Leveling Guide:

7+ Years with BA/ BS

5+ Years with MA/ MS

For jobs in the United States:
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