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Associate Director for Patient Safety, Center of Excellence

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POST DATE 8/14/2016
END DATE 10/23/2016

AstraZeneca Pharmaceuticals LP Gaithersburg, MD

Gaithersburg, MD
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Entry Level (0 - 2 years)


As the Associate Director for Patient Safety, Center of Excellence, about 30% of your role will be to coordinates and manages the Executive Safety Board (ESB) meetings. The ESB is a governance body responsible for providing endorsement and rapid decision-making authority for significant investigational and approved product safety issues with potential impact to patients, where escalation and/or harmonization of approach is required. THE ESB is also responsible for annual endorsement of safety content for information to external shareholders (i.e AZ Annual Report and AZ company website). The ESB Manager is responsible for the planning, conduct and follow-up of both scheduled and ad-hoc ESB meetings, including taking minutes of the ESB meetings and gaining approval of these minutes, maintaining a database for the ESB for archiving of minutes, the guidance process for approaching ESB and the policies and mandates relating to optimal functioning of the ESB. There are 2 scheduled ESB meetings/year and rest conducted on an as needed basis. The ESB is chaired by the CMO of Astrazeneca and in his/her absence by the Sr VP and Head of GRAPSQA (Global Regulatory Affairs, Patient Safety and Quality Assurance) br br In addition to ESB responsibilities, about 70% of the role has oversight responsibilities towards the TA specific SIRC (Safety Information Review Committee) meetings. These meetings are run by multiple Patient Safety Therapy Area Vice Presidents (TA VPs), and involve signal evaluation including, but not limited to, causality assessment and project safety decision related activities. There are about 3-5 meetings per month. It will be your responsibility to attend these SIRC meetings, be responsible for the minutes of the discussion, provide consistency for process across different TA SIRC meetings, guide decision on potential escalation of issues to ESB, as well as develop new SIRC processes and strategies, focusing on resolution, and deliver solutions back to the Patient Safety TA VPs. In this role, you will have a process oversight of SIRC meetings and also serve as the conduit between the relevant SIRC and ESB meetings. br br This role sits within the Patient Safety Center of Excellence, a part of GRAPSQA, a part of GMD organization within AZ and reports to the VP, PS CoE. br br