The Life Science Career Network

CTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services, support varied candidates in finding promising career opportunities and offer the latest in skill development training programmes.

Our client is a specialist biotherapeutics manufacturer with over a century of experience treating various diseases worldwide. They are committed to patients with coagulation disorders, immunological diseases, enzyme deficiency diseases and other rare diseases.

For an initial contract of 12 months (extension possible) we are currently looking for a:

Qualified Person Responsible for Pharmacovigilance (QPPV) Office Manager

based in Bern or remote work (possible just if based in Switzerland)

In this role you will develop, assess and improve processes to ensure that the QPPV can fulfil their legal obligations with regards to oversight of the company's worldwide pharmacovigilance (PV) system.

You will interact with multiple functions on a global basis to ensure implementation strategy of required changes to the PV system is aligned across different functions.

You will be responsible for the establishment and maintenance of regulatory required global documents and for the oversight over the development and maintenance of the local regulatory documents as required by national PV legislations.

Main Responsibilities:

  • Supporting the QPPV / Deputy QPPV to ensure appropriate oversight on the company’s entire PV system;
  • Providing a significant contribution to the company's compliance with global regulations, guidelines, and standards;
  • Establishing and ensuring maintenance of key regulatory required documents, i.e., the global PSMF in line with international regulations, guidelines, and internal standards.
  • Contributing to the development of an end-to-end PSMF management process and thus supports the local QPPV (LQPPV) / Safety Officer role nominated at local level in the PSMF management activities;
  • Acting as subject matter expert for PV in the company’s Regulatory Intelligence & Surveillance processes and expert network to analyse new/changing regulatory requirements;
  • Contributing to GxP assessments, User Requirements definition, vendor selection evaluation of such systems, and ongoing maintenance and enhancement of implemented tools and systems;
  • Developing, maintaining and reviewing procedural documents related to QPPV/QPPV Office processes.

Qualifications and Experience:

  • Bachelor or Master´s Degree in a life science discipline (e.g., Pharmacy);
  • At least 3 years in Pharmacovigilance or Regulatory areas, in the multinational pharmaceutical industry;
  • Holistic understanding of the global PV system, its quality system, and the dependencies of PV activities across the company;
  • In depth knowledge of international (especially EU/EEA) standards and regulatory requirements/regulations and processes related to pharmacovigilance;
  • Experience with relevant software applications and in administration of complex data sets.

Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us.