Pharmacovigilance Operations Manager - Thousand Oaks, CA | Biospace
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Pharmacovigilance Operations Manager

Amgen

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Location:
Thousand Oaks, CA
Posted Date:
8/19/2017
Position Type:
Full time
Job Code:
R-41525
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Amgen is seeking a Pharmacovigilance Operations Manager who will join our Pharmacovigilance Operations Enterprise Service Management (ESM) team. The Manager will report to the Senior Manager of the Pharmacovigilance Department and will work out of Amgen's Thousand Oaks, CA location.

The Pharmacovigilance Operations Manager will collaborate with cross functional teams to facilitate the development of comprehensive plans and coordinate the execution of safety deliverables for all molecules from FIH portal to post-marketing.

The Pharmacovigilance Operations Manager will be responsible for providing project management support and coordinating achievement of deliverables for Global Patient Safety. The incumbent will also be providing input to ensure alignment of global regulatory and safety plans cross-functionally and provide project management support for process improvement initiatives.

Key Activities for the Manager include:

  • Provides management and leadership of Global Patient Safety Project Management within a therapeutic area(s)
  • Ensures appropriate and consistent project management support is provided to safety teams within the therapeutic area(s)
  • Assumes leadership role for creation of departmental best practices in project management
  • Works as the project manager for Global Patient Safety deliverables, including facilitation of Safety Analysis Team and Global Safety Team meetings, tracking of safety deliverables, and management of safety reports and documents
  • Communicates plans, achievements, and milestones to a broad audience
  • Maintains knowledge of therapeutics area safety deliverables and provide comprehensive reports and Dashboards summarizing each products current and future activities
  • Provides project management support to Safety Analysis and Global Safety Team, including agendas, minutes and action item tracking
  • Identifies and creates communication and issue identification / resolution plans and manages timelines for safety deliverables
  • Facilitates Executive Safety Committee (ESC) meeting planning, slide preparation, meeting attendance, and follow-up on action items
  • Monitors and confirms data accuracy in safety systems for key deliverables
  • Undertakes activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as detailed in the PV System Master File and maintain a state of inspection readiness
  • Represents and acts as a point of contact for the Health Authority Inspection and Internal Process Audits within the remit of role and responsibility

Requirements

Basic Qualifications:

Doctorate degree

OR

Master's degree and 3 years of biotechnology and/or pharmaceutical experience

OR

Bachelor's degree and 5 years of biotechnology and/or pharmaceutical experience

OR

Associate's degree and 10 years of biotechnology and/or pharmaceutical experience

OR

High school diploma / GED and 12 years of biotechnology and/or pharmaceutical experience

Preferred Qualifications:

  • PMP certification and/or Project Management experience
  • Experience with execution of multiple major projects in a matrix environment
  • Industry and/or Regulatory/Safety experience
  • Understanding of Regulatory and Safety functional activities
  • Experience with conflict management and resolution with strong listening skills
  • Experience working cross-functionally and building collaborative working relationships; interfacing effectively with stakeholders, operations and management to resolve issues
  • Ability to organize and schedule tasks, develop realistic action plans incorporating time constraints and task priorities
  • Excellent Microsoft Excel, Word, and PowerPoint skills

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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.