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Senior Director of Global Pharmacovigilance

2 maanden geleden

Leiden, Zuid-Holland, Nederland Pharming Group Voltijd
About Pharming Group

Pharming Group is a global biopharmaceutical company dedicated to transforming the lives of patients with rare, debilitating, and life-threatening diseases. Our innovative portfolio of protein replacement therapies and precision medicines is in early to late-stage development, with a focus on bringing solutions to unserved rare disease patients.

Our Culture

We are committed to our core values: "We Care, We Collaborate, We Walk the Talk", which enables our mission of creating a clear pathway forward to meet our strategic goals and objectives. Our culture is built on self-development, teamwork, leadership, and being results-oriented.

The Role: Senior Director Pharmacovigilance

The Senior Director Pharmacovigilance is responsible for the global safety strategy and overall safety profile for assigned Pharming products throughout their lifecycle. This includes leading major pre-and post-marketing safety related deliverables, such as safety evaluation, benefit-risk evaluation, and risk management activities.

This individual will work together with other drug safety team members to oversee processing of (S)AE reporting, management of (S)AE data, and responses to safety requests from Competent Authorities worldwide. Key responsibilities include:

  • Review of individual, aggregate, and scientific literature of Adverse events
  • Preparing safety reports and communicating changes in the product risk profile to internal and external stakeholders
  • Effective interface with cross-functional teams and external Competent Authorities
  • Management of the Director and PV Manager(s) and Associate(s) to ensure successful performance

The Senior Director will also support the Vice President PV/EU QPPV in ensuring the smooth running of the Global Pharmacovigilance Department.

Requirements

To be successful in this role, you will need:

  • A Doctor of Medicine (MD) degree; clinical research and/or fellowship training in pharmacology or other relevant specialty is a plus
  • Excellent knowledge in pharmacovigilance operations, especially from case processing and reporting perspective
  • In-depth understanding of good pharmacovigilance practices (GVP) Modules and current drug safety/pharmacovigilance regulations
  • Good knowledge of GCP/ICH guidelines
  • Experience in planning, allocating, and managing multiple projects
  • Strong interpersonal skills with ability to handle conflict situations, think strategically, generate solutions to problems, and build consensus across departments internally and suppliers externally
  • Computer proficiency
What You'll Get in Return

We offer a permanent position with an excellent remuneration scheme, including:

  • A highly competitive salary
  • Holiday allowance (for NL)
  • A minimum of 30 vacation days
  • An excellent pension plan
  • Commuting allowance

You will also join our Learning & Development program, which offers a tailor-made development plan based on your personal and professional needs. We value a healthy life-work balance with a lot of flexibility.