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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:
Your profile:
Your Benefits
Further information
Annual gross salary from € 50,000,- based on professional qualifications and experience.
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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