QA/Compliance Director – Pharmacovigilance – Thousand Oaks, CA OR Cambridge, UK
Posted: January 21, 2017
Reference ID: R-32956
The Compliance Director for Pharmacovigilance (PV) is a global role that is responsible for Amgen's PV compliance program worldwide, leads a team of PV compliance professionals, and serves as the company expert on compliance with global PV requirements. Specific responsibilities include:
Lead and coordinate PV compliance risk assessments, including for purposes of providing input into the annual R&D audit program
Provide expert compliance advice on PV strategies, programs, processes, initiatives and activities (including labeling) to help manage and mitigate risk
Manage, facilitate and support regulatory agency inspections
Ensure compliance oversight for the implementation, management, and monitoring of operational activities supporting Amgen's Risk Evaluation and Mitigation Strategy (REMS) programs.
Lead and develop staff to ensure proactive and timely identification and effective management of PV compliance issues
Facilitate timely and appropriate remediation and response to PV findings from internal audits and regulatory agency inspections
Report and escalate significant compliance issues to R&D Compliance management and senior PV stakeholders
Serve as PV Compliance representative on senior compliance/ quality oversight bodies
Review and analyze audit, inspection and CAPA data to identify compliance trends and areas of exposure related to pharmacovigilance
Develop and deliver periodic PV compliance reports, including relevant metrics, to key stakeholders and management
Assess PV impact of changes in new regulations and the external environment and advise stakeholders accordingly
10-15% travel, depending on location.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.