Job description

Requirements

  • Entry level
  • No Education
  • Salary to negotiate
  • Breda

Description

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

About the company

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.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.

Special Advisory: Please be cautious of scam recruitment offers claiming to be from Amgen. Such scams may come from various sources, including fake websites and/or unsolicited emails and seek to obtain personal data or payment from victims by offering jobs that do not exist. Please be advised that Amgen would never ask for payment to progress a job application. When in doubt, please check to see if the position in question is posted on this website before applying. Additionally, please report any suspicious recruiting activity to https://complaint.ic3.gov/ and thank you for your assistance.

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