(Deputy) Head of Pharmacovigilance at HAL Allergy

Job purpose:

The (deputy)  Head of Pharmacovigilance is responsible for:

  • the establishment and maintenance of the pharmacovigilance system in full compliance  with the European regulations,
  • having insight into the risk-benefit profiles and clear overview of any emerging safety concern with HAL Allergy products;
  • serving a contact point for regulatory authorities for pharmacovigilance and clinical safety issues on behalf of the company.

Responsibilities:

  • Co-creates and manages an in-house and external pharmacovigilance team.
  • Co-responsible for the growth and adaptation of the pharmacovigilance department to meet the needs of the company.
  • Responsible to ensure the development and execution of safety education and training of employees and vendors.
  • Responsible for the performance of post-approval surveillance studies
  • Implements policies, systems and a culture to ensure ongoing compliance of pharmacovigilance requirements.
  • Co-responsible for the pharmacovigilance-related budgets.
  • Leading (interdisciplinary) projects as appropriate.
  • Act as Head of Pharmacovigilance in the absence of the Head.
  • Acts as EU-QPPV, in absence of the Head.

Qualifications:

  • Medical Degree or advanced degree in health care with similar experience meeting the requirements to act as EU-QPPV in the EU;
  • At least 5 year pharmacovigilance/drug safety experience in the pharmaceutical/health care industry both in clinical development and post approval period;
  • Expert knowledge of pharmaceutical regulations, standards, current industry practices and strong experience with interpretation and application;.

Personal & Professional Skills:

  • Hands-on mentality and flexibility to act in an heavily regulated environment.
  • Meeting established schedules and resolving technical and operational challenges in a matrix environment.
  • Ability to manage and build a team, and relationships with other colleagues and external experts.
  • Excellent written and oral communication and presentation skills.
  • Punctual, accurate and precise way of working.
  • Wide experience in PV-specific databases.
  • Basic knowledge of epidemiology & pharmaco-epidemiology methods and biostatistical analysis.
  • Implementation of regulations in day to day practice.
  • Ability to identify risks, and make decisions independently and escalate issues when necessary.
  • Confident, pro-active, team spirit and the ability to work under time pressure.
  • Fluent in English, both oral and written. German basic language skills or willingness to learn German language.
  • Good MS-Office skills.

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