Director Global Patient Safety (GPS) and EU QPPV

Category: Safety
Job ID: R-66776
Employment Type: Full time
Location: Netherlands – Breda
Posted Date: December 7, 2018

Amgen is a values-based organization with a powerful sense of shared purpose toward our mission: to serve patients. We provide the capabilities, resources, and rewards of a global enterprise, while maintaining the entrepreneurialism and pioneering spirit that marked our early days as a biotechnology innovator.

At Amgen Breda (ABR) medicines are labelled, assembled, stored and eventually shipped to various countries worldwide. Amgen Breda receives its products as semi-manufactured goods, which are then packed country-specific, stored and eventually shipped to various countries worldwide.

Every day more than 600 people in the Netherlands are working on supply chain processes, Engineering, marketing and sales of our medicines and clinical research into new medicines.

We encourage our team members to have fulfilling and meaningful careers through challenging assignments, career development, and valuable opportunities such as this:

Director Global Patient Safety (GPS) and EU QPPV

In this role you work to ensure the establishment and maintenance of a quality pharmacovigilance system for Amgen.

You oversee Amgen compliance with EU pharmacovigilance regulations and requirements and are the single point of contact for competent authorities in Europe.

As a Director Global Patient Safety you are responsible for the overview of safety profiles and emerging safety concerns for all Amgen products authorized in the EU. You oversee the maintenance of the pharmacovigilance system master file (PSMF) to harmonize and strengthen the conduct of pharmacovigilance activities in the EU.

The EU Qualified Person for Pharmacovigilance is responsible for ensuring the establishment, maintenance and improvement of the Amgen PV System thereby safeguarding Amgen’s pharmacovigilance commitments for products authorized in the EU. They are assisted in this role by a team of QPPV Office staff.

Key elements of the role:

  • Ensures the establishment and maintenance of the Pharmacovigilance System Master File (PSMF) at Amgen
  • Ensure the pharmacovigilance system has been implemented in accordance with the requirements in EU legislation
  • Is a participating member of the Safety governance bodies at Amgen (e.g., Executive Safety Committee, Executive Labelling Board, Safety Compliance Committee)
  • Confirms that the information contained in the pharmacovigilance system master file is accurate and is an up to date reflection of the Amgen pharmacovigilance system and is accessibl
  • Assure proper delegation documentation is in place where appropriate
  • Works with the multiple departments at the MAH to have processes in place so that the QPPV is informed appropriately about any possible changes to the Amgen PV system and can provide appropriate input and oversight of any changes to the PV system.
  • Ensures that back up procedures in the case of absence of the QPPV are in place and are accessible. The QPPV must ensure that the backup person has all necessary information to fulfil the role of QPPV if necessary.
  • Responsible for promoting, maintaining and improve compliance with the PV legal requirements in Europe
  • Overview of safety profiles and any emerging safety concerns with Amgen product authorized in the EU
  • Awareness of any conditions or obligations adopted as part of the marketing authorizations and other commitments relating to the safety of the products authorized in the EU
  • Review of risk minimization measures and review of the content of risk management plans
  • Ensures the conduct of pharmacovigilance (PV) and submission of all pharmacovigilance related documents in accordance with legal requirement and GVP
  • Ensures the necessary quality including the correctness and completeness of PV data submitted to the Competent Authorities (CA) in Member States and the Agency
  • Ensure prompt response to any request by the CA in the Members states for the provision of additional information necessary for the Benefit-risk evaluation of a medicinal products
  • Provides input into the preparation of the regulatory action in response to emerging safety concerns
  • Acts as a single PV contact point for the CA in Member States and the European Medicines Agency on a 24 hours basis and also as a contact point for PV inspections
  • Oversight of compliance in the EU region
  • Department Development and Management Responsibilities

Education and experience

MD or DO degree from an accredited medical school with 4 years of directly related experience including EU PV regulations and guidance

or
Doctorate, PharmD or Master’s degree in healthcare and 6 years of directly related experience including EU PV regulations and guidance
or
Bachelor’s degree in healthcare and 8 years of directly related experience including EU PV regulations and guidance
and
2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred:

  • MD/PhD/DO/PharmD
  • Previous QPPV Experience
  • Proven history of effective leadership with a matrix organization
  • Experienced in regulatory agency interactions
  • Issue and crisis management

Why join Amgen?

Amgen is a Fortune 150 company and one of the world’s leading biotechnology companies operating in nearly 100 countries around the world. We are a values-based company, deeply rooted in science and innovation to transform new ideas and discoveries into medicines for patients with serious illnesses.

We invest in highly skilled, dedicated and collaborative individuals who are ready to contribute to our mission in meaningful ways and make a difference in the lives of our patients. That’s why, we provide you with valuable opportunities to broaden your experience and maximize your potential in a modern working environment.

We encourage open dialogue and professional debate, and we collaborate with world-class talent and institutions around the globe. We believe in rewarding those who do rewarding work and are committed to providing careers that can help turn the tide of serious, life-interrupting illnesses.

The recruitment process
The high-level recruitment process is as follows: resume screening, first phone screening, assessment invitation, face to face interviews.

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