Drug Safety Manager - Wien, Österreich - AOP Orphan Pharmaceuticals GmbH

AOP Orphan Pharmaceuticals GmbH

Geprüftes Unternehmen

Wien, Österreich

vor 3 Wochen

Geschrieben von:

Anna Müller

beBee Recruiter

Beschreibung

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):

1190 Vienna
Fulltime employee

**- As member of the Drug Safety team you collect safety information from various sources, SAE reconciliation, quality control of safety Data entry, and compliance of individual case safety reports (ICSR) to regulatory authorities and business partners._

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What Your Day To Day Will Look Like
**- Implement and coordinate all pharmacovigilance processes in accordance with the regulatory requirements and applicable SOPs

Create and maintain pharmacovigilancerelevant documents on time
Compile and control Periodic Safety Update Reports (PSUR)
Manage creation and update of Risk Management Plans (RMPs) as well as implementation of additional Risk Minimization Measures (aRMMs)
Carry out signal management tasks and lead Safety Review Meetings (SRMs)
Compile and process incoming safety case reports (ICSR) in cooperation with medical experts
Ensure the compliance of our partners and act as their contact person
Support the planning and implementation of PV audits

Your

Qualifications and Experience
**- Completed scientific studies/ technical college degree

Several years of experience in the field of pharmacovigilance / drug safety
Indepth knowledge of the relevant laws and regulatory requirements for pharmacovigilance
Stressresistant personality with accuracy in documentation
Strong communication skills in English and German
IT skills (Office 365, Adobe Acrobat)

Our Offer
**- Open corporate culture with the opportunity to bring in your own ideas

Great opportunities for personal and professional development
Attractive work environment with excellent career opportunities and flat hierarchies
Competitive salary package plus bonus and various benefits
Structured onboarding and a buddy system
Gross monthly salary provided for this function is a minimum of EUR based on fulltime employment. Any potential overpayment depends on professional experience and qualifications.
If you would like to work as a team player in an international environment and can identify with our values "Agile, Ambitious, Aligned, Accountable and Appreciative"_

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Introduction:

Main Benefits: