Job Overview
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
+43-664-88963746
