Amgen Global Patient Safety Senior Associate -Product Manager in Thousand Oaks, California

Amgen is seeking a Global Patient Safety Senior Associate - Product Manager to work out of their Thousand Oaks, CA location.

The Global Patient Safety group facilitate the development of comprehensive plans and coordinate the execution of safety deliverables for Therapeutic Area Safety product subteams.

The Global Patient Safety Sr. Associate position is responsible for:

  • Providing project management support and coordinating achievement of deliverables for Therapeutic Area Safety subteams as assigned

  • Providing input to ensure alignment of global regulatory and safety plans cross-functionally for teams assigned

  • Ensure appropriate and consistent project management support is provided to safety teams within the therapeutic area(s)

  • Contribute to creation of departmental best practices in project management

  • Work as project manager for Global Patient Safety deliverables, including facilitation of Safety Governance meetings (e.g. Global Safety Team meetings and Safety Analysis Team meetings), tracking of safety deliverables, and management of safety reports and documents

  • Maintain knowledge of therapeutics area safety deliverables and provide comprehensive reports and Dashboards summarizing each products current and future activities

  • Provide project management support to Global Safety Team, including agendas, minutes and action item tracking

  • Identify and create communication and issue identification/resolution plans

  • Create and manage timelines for safety deliverables

  • Facilitate Executive Safety Committee (ESC) meeting planning, slide preparation, meeting attendance, and follow-up on action items

  • Liaise with Commercialization Research and Development Compliance (CRDC) and other project management groups to ensure alignment of safety plans with the cross functional product plan

  • Monitor and confirm data accuracy in safety systems for key deliverables

  • Undertake activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as detailed in the Pharmacovigilance (PV) System Master File and maintain a state of inspection readiness

  • Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility

Basic Qualifications:

Master's degree

OR

Bachelor's degree & 2 years of Scientific or Healthcare and/or Pharmaceutical/Biotech industry experience

OR

Associate's degree & 6 years of Scientific or Healthcare and/or Pharmaceutical/Biotech industry experience

OR

High school diploma / GED & 8 years of Scientific or Healthcare and/or Pharmaceutical/Biotech industry experience

Preferred Qualifications:

  • BS Degree

  • 2+ years

  • PMP or CAPM certification

  • Execution of multiple projects in a matrix environment

  • Project management experience

  • Understanding of Regulatory and Safety functional activities

  • Application of project management principles

  • Action oriented

  • Experience dealing with ambiguity

  • Effective conflict management experience

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.