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Medical Safety Specialist (m/w/d)

Wien
Medizintechnik
Vollzeit
We are filling the position as a Medical Safety Specialist (m/f/x) for our client located in the heart of Vienna (Austria) 
 

Medical Safety Specialist (m/f/x)

Your Responsibilities: 
  • Set up a Vigilance System in collaboration with QM (update PCMF/PMS, update QPs/SOPs) 
  • Set up literature search 
  • Ensure readiness for vigilance inspection in collaboration with QM 
  • Implement Change Control Procedures, if necessary, during life cycle management, e.g. variations triggered by safety measures 
  • Responsible for monitoring and reporting the effectiveness and any adverse effects or side effects (AEs/SAEs/SADEs/ASADEs/USADEs) 
  • Perform and maintain consistency of safety assessments 
  • Serve in cross-functional teams as a medical and scientific representative 
  • Ensure regulatory compliance and safety throughout a clinical trial 
  • Submit periodic reports to the competent authorities 
  • Ensure that medical and causality assessments of all clinical and post-marketing adverse event fillings to regulatory authorities are consistent with company policies, as well as the respective regulatory requirements 
  • Assist with internal and external safety audits 
  • Remediate any vigilance deficiencies found during regulatory or internal audits 
  • Act as medical expert during product development 
  • Ensure subject safety during clinical studies 
  • Identify the correct actions and facilitate, support and implement them as appropriate in collaboration with QM 
  • Review performance metric data and clarify inconsistencies and trends. 
 
Your profile: 
  • Minimum Bachelor’s Degree in Scientific Disciplines (MD, Pharmacy or similar)
  • Relevant experience in Pharmacovigilance activities, or Medical Device Regulatory Affairs or Medical Device Quality Assurance 
  • Knowledge of US and EU vigilance regulatory requirements (eg. MDR) 
  • Knowledge of current pharmacovigilance practices 
  • Knowledge of drug safety databases (e.g. ARISg) is a plus •     Ability to evaluate, interpret and synthesize scientific data. 
  • Proficiency with safety coding dictionaries (eg, MedDRA, WHODRUG) 
  • Expertise in individual safety case report processing, including triage, data entry, quality review, and submission. 
  • Requires understanding of how the team / work area relates to other related areas and uses that knowledge to improve efficiency and produce high-quality work on problems with crossfunctional impact 
  • Identifies and resolves technical, operational and organizational problems/problems relating to own discipline 
  • Frequently works cross-functionally as the representative for their area 
  • Team player with ability to function in a multi-disciplinary environment 
  • Self-motivated, detail oriented, and able to prioritize and plan effectively 

 Your Benefits
  • Central Location in 1st District of Vienna
  • International Environment
  • Workplace Well-Being
  • Possibility to work partly remote

Further information

Annual gross salary from € 50,000,- based on professional qualifications and experience.

 

 
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