Senior Manager, PV System Master File (PSMF)

At Genmab, we are dedicated to building extra not ordinary futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.

Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.

Does this inspire you and feel like a fit? Then we would love to have you join us!

Introduction

As a Marketing Authorization Holder in Europe, Genmab is required to maintain a Pharmacovigilance System Master File (PSMF) on an ongoing basis. The PSMF provides a comprehensive description of Genmab's pharmacovigilance (PV) system for all medicinal products authorized in the EEA and the UK. It is a key tool that enables the Qualified Person for Pharmacovigilance (QPPV) to maintain oversight of the PV system.

Maintaining the PSMF is a regulatory requirement in both regions, and it must be available to competent authorities upon request, typically within 7 days.

The Role

As a PSMF Manager, you will be responsible for ensuring the file is continuously updated, submission-ready, and fully compliant. This critical role sits within the QPPV Office. This position offers a hybrid work model (60-80% onsite) and will be based in Genmab's headquarter in Copenhagen.

Responsibilities

The key responsibilities of the PSMF Manager:

• Maintaining the Genmab PSMF, through:
  • Acting as a project lead to coordinate input from multiple key stakeholders across the organization, ensuring adherence to timelines and compliance with current regulations
  • Ensuring stakeholders are trained in PSMF requirements and their responsibilities
  • Planning, facilitating, and documenting PSMF update kick-off meetings with relevant stakeholders
  • Ensuring the PSMF is readily available to the QPPV
  • Ensuring the PSMF can be provided to competent authorities upon request
  • Collaborating with the QPPV to assess and address regional PSMF requirements
  • Supporting the development of local PSMFs or specific local content as required by national competent authorities, in collaboration with the relevant local QPPV(s)
• Actively contribute to process improvement initiatives related to the QPPV Office and PSMF, including the development, revision, and maintenance of relevant Standard Operating Procedures (SOPs), Work Instructions (WIs), and supporting documents
• Serve as process owner and author for SOPs, WIs, and guidance documents relevant to the Genmab PSMF
• Schedule QPPV Office meetings, ensure participation of relevant subject matter experts, prepare and present metrics/data, and document meeting outcomes, actions, and decisions through formal minutes
• Support collaboration with vendors and distributors around contractual matters
• Coordinate and schedule ad-hoc meetings with key stakeholders, including managing pre-read materials and taking meeting minutes
• Review PV quality, compliance, and performance data in collaboration with the QPPV to ensure the pharmacovigilance system is functioning effectively
• Collaborate with Genmab Quality Assurance (QA) and GDS&PV Compliance on audits involving the QPPV Office and PSMF (including Business Partner audits), and own applicable Corrective and Preventive Action (CAPA) plans when required
• Monitor and oversee the QPPV Office mailbox daily
• Perform additional tasks as assigned by the Manager

Requirements

• At least 2-3 years of experience in pharmacovigilance, preferably in a similar QPPV Office position.
• Preferably also experience in managing a PSMF.
• Suitable experience and qualifications to be able to demonstrate the capabilities to maintain oversight of the Genmab PSMF (stakeholder management, project lead skills).
• Flair and interest in process development and quality management within PV.
• Suitable understanding of all major aspects of PV - particularly as applicable in the EU/UK, but also as applied in other territories (guidelines, legislation etc.)
  

About You

• You are genuinely passionate about our purpose

• You bring precision and excellence to all that you do

• You believe in our rooted-in-science approach to problem-solving

• You are a generous collaborator who can work in teams with a broad spectrum of backgrounds

• You take pride in enabling the best work of others on the team

• You can grapple with the unknown and be innovative

• You have experience working in a fast-growing, dynamic company (or a strong desire to)

• You work hard and are not afraid to have a little fun while you do so!

Locations

Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you're in one of our office spaces or working remotely, we thrive on connecting with each other to innovate.

About Genmab

Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO ) antibody medicines.

Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit and follow us on LinkedIn and X .

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