Pharmacovigilance & Regulatory Affairs Manager

7 dagen geleden

Utrecht, Utrecht, Nederland Alfasigma Voltijd € 60.000 - € 120.000 per jaar

Location:
Netherlands or Belgium, Flanders

Currently, we are looking for a
Pharmacovigilance and regulatory affairs manager BeNeLux

Job Summary

Responsible for overseeing Regulatory affairs and Pharmacovigilance activities across the BeNeLux region, acting as the primary local contact for both internal stakeholders (local and global teams) and external partners (National Competent Authorities and consultants). Serves as the designated Local Safety Officer for the BeNeLux, maintaining high standards of patient safety and regulatory integrity.

Your role:

  • Act as local single point of contact for global functions in Regulatory Affairs and Pharmacovigilance for the BeNeLux
  • Act as the Local Safety Officer (LSO) for the Netherlands, Belgium and Luxembourg
  • Act as primary contact for regulatory authorities and for external consultants, ensuring compliance of Product Information, approval of artworks for packaging materials and implementation of aRMM
  • Responsible for creating and keep the local Regulatory affairs and Pharmacovigilance SOPs up to date
  • Responsible for training of BeNeLux team in local Regulatory affairs and Pharmacovigilance SOPs
  • Work closely together with Pharmacovigilance and regulatory affairs managers within the BNS cluster (BeNeLux Nordics and Switzerland) creating a network of knowledge and international cooperation and support
  • Collaborate with commercial, medical and market access to realize cross-functional objectives

Profile description:

Who are you?

  • Minimum 5-10 years of experience in regulatory affairs and pharmacovigilance within pharmaceutical company
  • Knowledge of local pharmaceutical legislation for Regulatory in the BeNeLux region
  • Knowledge of applicable laws and regulations to ensure full compliance
  • Knowledge of Regulatory affairs and Pharmacovigilance activities (act as primary contact for regulatory authorities and for external consultants in the regions, ensuring compliance of Product Information, API, approval of artworks for packaging materials and implementation of aRMM)
  • Proficiency in speaking, comprehending, reading and writing Dutch is required.
  • Proficiency in speaking, comprehending, reading and writing English is required.
  • Proficiency in speaking, comprehending, reading and writing French is a plus.
  • Ability to think strategically & execute tactically

What We Offer

  • A dynamic and growing pharmaceutical environment.
  • An ambitious, successful team to work with.
  • Opportunities for professional growth and development.
  • Competitive salary and benefits package.

Why Join Alfasigma:

At Alfasigma, we foster a culture where the courage to innovate is key to our success.

We offer a competitive salary, comprehensive benefits, and extensive opportunities for professional growth and development.

Our commitment to people and patients is at the heart of everything we do. We value diversity and welcome individuals with unique perspectives and experiences. We believe that open-mindedness, collaboration, and a shared passion for innovation are essential to achieving meaningful progress.

Join Alfasigma and become part of a forward-thinking team dedicated to shaping the future of the pharmaceutical industry.

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