Medical Safety Specialist (m/w/d)

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.