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 Senior Associate Drug Safety (f/m/d).
As member of the Drug Safety Team of the Global Group you are involved in the management of the global and local PV agreements and worldwide PV network of affiliates and partners with main focus on US market.
What Your Day To Day Will Look Like
- Management of pharmacovigilance agreements for US PV system and maintenance of routine updates for all PV partners
- Management of PV network for US by distributing relevant information and documents to partners and US affiliate, arranging regular meetings and by supporting especially US affiliate with the local PV activities (including local PV trainings and local Standard Operating Procedures (SOP) related to pharmacovigilance)
- Monitoring of partner and affiliate performance and compliance for US, including audit and Corrective and Preventive Actions (CAPA) management
- Contribution to global PV system master file to reflect US PV system
- Contribution to processes for the global PV system, especially PV trainings, worldwide PV network and compliance monitoring of partners and affiliates
Your Qualifications and Experience
- Completed scientific studies / technical college degree
- Basic knowledge of PV regulation (at least 1 year experience preferred)
- Knowledge of US regulation preferred
- Excellent skill in self-organisation, structured and accurate working
- Open-minded personality with out-of-the-box thinking to develop new processes and to proactively improve existing processes
- 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
- Gross monthly salary provided for this function is a minimum of EUR 3.200.- based on full-time employment. Any potential overpayment depends on professional experience and qualifications.
