Amerit Consulting
San Ramon, CA
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Job Description :
Company Overview:

Creating value by bringing together the right people to achieve results is our motto. Our clients and employees say they choose to work with us because of how we work with them - with service that exceeds their expectations and a personal commitment to their success.

Our client, is the world''s largest independent multinational biopharmaceutical company, seeks an accomplished Senior Safety Manager.


Notes:
Red Flags: No experience using software programs and internal data repositories, no experience in safety in biopharmaceutical industry.
Interview Process: Phone & in-person interview.

Description:
To provide support to Safety Risk Management in terms of inspection readiness, tracking of program deliverables, quality assessments, operational projects and team deliverables through problem solving, solution development and consistent project execution.
This role will support Safety Risk Management team activities, cross functional projects, and help the team prepare for upcoming inspection by regulatory authorities.
Under direction of Global Risk Management Officer, conduct projects associated with a continuous process improvement and inspection-readiness focus.
Review archived EU Risk Management Plans and corresponding Core Risk Management Plans in regard to their Safety Specifications. Where discrepancies are noted, review associated Global Safety Team meeting minutes to determine team discussion.
Track and compile data on key aspects of programs operations on a monthly and quarterly basis (e.g., number of core Risk Management Plans approved
As needed, provide operational support to Global Risk Management Officer and other team members, including operational project management and implementation of functional projects.
May manage aspects of logistical support for meetings. Facilitate team of functional ops leads to maximize GRAAS information flow and project efficiency. Support other business initiatives as assigned.

Requirements:
Bachelor’s degree and 5 years of directly related experience in biopharmaceutical safety operations OR Associate’s degree and 10 years of directly related experience in biopharmaceutical safety operations OR High school diploma / GED and 12 years of directly related experience in biopharmaceutical safety operations.
Microsoft Office applications.
Experience using data repositories (e.g., EPIC
Attention to detail. Strong communication skills. Tolerance for ambiguity. Ability to research and compile information.
Organizing resources and establishing priorities. Ability to influence. Self-confidence and self-motivation. Critical thinking. Time management. Good interpersonal skills.



I''d love to talk to you if you think this position is right up your alley.

If you''re looking for rewarding employment and a company that puts its employees first, we''d like to work with you. We''re driven, people driven. We also offer group health Insurance (employee paid on a pre-tax basis

NOTE: “Candidates that are offered a position are required to pass pre-employment drug and background screening”
             

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