30 days old

Global Patient Safety Head of PV Compliance and Training

Amgen
Thousand Oaks, CA 91360
  • Job Code
    131780119
Amgen

Job ID: R-114063
Location: Thousand Oaks, CA, US

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Join us.

Global Patient Safety Head of PV Compliance and Training

Live

What you will do

Let's do this. Let's change the world. In this vital role you will be responsible for strategic and operational PV compliance support for Global Patient Safety (GPS), to ensure that GPS has a strong PV quality and compliance system. This position is also responsible for developing a capabilities roadmap that aligns with the GPS strategies. Additionally, the role is accountable for supporting the delivery of high-quality PV training to GPS which is compliant with internal SOPs and GVP Module I. Working closely with R&D Quality, the Head of PV Compliance and Training will prepare quality and process performance metrics and provide strategic oversight for training for the function in addition to training metrics.

Principal responsibilities include:

  • Ensuring the oversight and coordination of PV activities, PV SMEs, and PV deliverables during inspections and audits, in coordination with the EU QPPV when applicable
  • Supporting both external and internal inspections and audits worldwide
  • Collaborating with Quality, Compliance and Audit (QCA) to ensure timely audit and inspection responses for Global Patient Safety and appropriate ownership of corrective and preventative action plans (CAPAs) by PV subject matter experts (SMEs) worldwide
  • Collaborating with the Global Patient Safety sub-functions to ensure compliance tracking processes and inspections and audit procedures/processes are in place that reflect alignment with various regulatory authorities' regulations worldwide
  • Ensuring that adequate global processes are in place to maintain current knowledge of compliance and relevant PV regulations, including evolving changes in the regulations that may impact compliance.
  • Participating in and overseeing talent management strategies such as annual reviews, performance management, succession planning and employee development and retention


Accountabilities:

  • Leads the development of GPS compliance programs and quality tools to enhance GPS quality and adherence to SOPs and regulations, in coordination with the EU QPPV as applicable.
  • Collaborates with the LSO Heads, to support inspections at local sites.
  • Ensures that the PV compliance standard operating procedures and quality documents locally are aligned, consistent, and meet global requirements.
  • In conjunction with QCA, ensures PV regulatory inspection and internal audit readiness for dedicated PV or GCP inspections/audits.
  • Ensures that PV Compliance data is readily available for inspections and audit purposes.
  • Ensures that all Global PV inspection and audit issues and findings are addressed adequately, in coordination with the EU QPPV as applicable.
  • Ensures appropriate identification of CAPA owners within Global Patient Safety sub-functions.
  • Serves as the primary contact with QCA for escalation of PV CAPA compliance.
  • Designs and implements appropriate mechanisms for maintaining and communicating compliance information across Global Patient Safety sub-functions.
  • Collaborates with QCA and all relevant Global Patient Safety sub-functions in the development and management of CAPA including assessment of root cause and establishment of timeframes.
  • Directs regular assessment of adequate PV compliance metrics related, but not limited to, expedited and periodic PV regulatory reporting to relevant regulatory authorities for case processing and aggregate safety reporting, and their timely and adequate distribution to local countries and PV business partners.
  • Supports the development and implementation of PV systems in compliance with PV regulatory requirements worldwide in collaboration with the QCA.
  • Collaborates with the Company training group in the development of training strategies to ensure that GPS processes meet PV compliance and regulatory requirements worldwide.
  • Escalates issues / problems related to PV compliance to senior management in a timely manner and as needed.
  • Creates and executes an effective Education strategy that drives company compliance and positions PV as a department of compliance and operational excellence.
  • Oversees the design, development, implementation, and execution of curriculum that provides the organization with the needed knowledge to meet regulatory requirements worldwide including monitoring of training compliance of personnel in relation to pharmacovigilance.
  • Supports Local Safety Officers to assure that local training curriculums meet local regulatory compliance requirements.
  • Performs ongoing needs analysis to ensure learning solutions meet and/or exceed compliance requirements.
  • Supports the design and development of competency-based learning plans and training matrixes.
  • Researches and transforms management strategy into tactical and efficient application(s) via training, coaching and other learning solutions.
  • Creates and evaluates effective external training vendor partnerships.
  • Oversees training initiatives to match all department projects and objectives.
  • Evaluates content of training programs to ensure that curriculum will meet PV regulatory requirements worldwide and GPS goals and objectives.
  • Actively establishes open communication between GPS functional areas regarding training issues towards problem solving.
  • Maintains understanding of roles and responsibilities of all GPS functions worldwide to ensure appropriate training curriculums exist to meet PV compliance regulatory requirements.
  • Engages with senior executives to gain support of PV training initiatives, training compliance and to gather insight for training needs as needed.


Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The safety professional we seek is a cross-functional leader with these qualifications.
  • Doctorate degree and 4 years of Safety experience
  • OR Master's degree and 8 years of Safety experience
  • OR Bachelor's degree and 10 years of Safety experience


Thrive

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.
  • Vast opportunities to learn and move up and across our global organization
  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits


Apply now for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us. careers.amgen.com

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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.





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Posted: 2021-03-11 Expires: 2021-04-11

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Global Patient Safety Head of PV Compliance and Training

Amgen
Thousand Oaks, CA 91360

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