Drug Safety Manager (f/m/d)

AOP Orphan Pharmaceuticals GmbH

Job Overview

AOP Health

AOP Health is the European pioneer for integrated therapies for rare diseases and in critical care. To enhance our team in Vienna we are looking for a:

Drug Safety Manager (f/m/d)

Professional Skills

  • Completed scientific studies/ technical college degree
  • Several years of experience in the field of pharmacovigilance / drug safety
  • In-depth knowledge of the relevant laws and regulatory requirements for pharmacovigilance
  • Stress-resistant personality with accuracy in documentation
  • Strong communication skills in English and German
  • IT skills (Office 365, Adobe Acrobat)

Ready for an ambitious job?

  • You implement and coordinate all pharmacovigilance processes in accordance with the regulatory requirements and applicable SOPs
  • You create and maintain pharmacovigilance-relevant documents on time

Like to take accountability?

  • You compile and control Periodic Safety Update Reports (PSUR)
  • You manage creation and update of Risk Management Plans (RMPs) as well as implementation of additional Risk Minimization Measures (aRMMs)
  • You carry out signal management tasks and lead Safety Review Meetings (SRMs)

Able to align?

  • You compile and process incoming safety case reports (ICSR) in cooperation with medical experts
  • You ensure the compliance of our partners and act as their contact person
  • You support the planning and implementation of PV audits

Looking for an agile environment?

  • You enjoy working in our growing international company introducing solutions for rare diseases to new markets
  • You prefer a high degree of independence and responsibility for assigned projects
  • You are keen to manage multiple projects and being able to prioritize and self-manage

The gross monthly salary provided for this function is a minimum of € 3.500.- based on full-time employment. Any potential overpayment depends on professional experience and qualifications.

Take this AOPPORTUNITY and apply now.

Your contact
Angelika Drabek

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