Compliance Senior Manager - Pharmacovigilance

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POST DATE 9/16/2016
END DATE 10/17/2016

Amgen Thousand Oaks, CA

Company
Amgen
Job Classification
Full Time
Company Ref #
360935
AJE Ref #
576197381
Location
Thousand Oaks, CA
Experience
Entry Level (0 - 2 years)
Job Type
Regular

JOB DESCRIPTION

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p This is an exciting opportunity for a Compliance Senior Manager position within Amgen's Global R&D Compliance and Audit (GRDCA) organization. This position reports directly into the Compliance Director, Pharmacovigilance (PV), and is primarily accountable for providing compliance support to Amgen's Global Patient Safety & Labeling organization. /p p /p p The Compliance Senior Manager, Pharmacovigilance must be able to assess and manage pharmacovigilance compliance risk, including providing input into the development of the annual audit program. This position is based in US corporate headquarters (Thousand Oaks) and may require occasional travel within the US and also to international inspection sites. /p p Key responsibilities include: /p ul li Managing compliance programs for assigned pharmacovigilance areas /li li Providing compliance oversight and advice for pharmacovigilance programs, initiatives, and activities in line with current best practice /li li Managing, facilitating and supporting regulatory authority inspections /li li Leading or participating on GRDCA and R&D process improvement initiatives /li li Collaborating with other Amgen compliance/quality groups to manage cross-disciplinary and cross-functional compliance programs and issues /li li Providing input on pharmacovigilance processes and training programs /li li Advising on remediation of pharmacovigilance compliance issues /li li Serving as compliance point of contact for assigned geographic area /li /ul p /p p