Product Safety Associate (PSA)
For one of our key clients are we looking for a Product Safety Associate (PSA) with a focus on medical devices in the Frankfurt area.
Our client is a group that is very active in the pharmaceutical and medical device industry.
If you have very good IT skills in the field of medical devices vigilance and are interested in working for a huge company, then you should not wait to get in contact with me.
Your responsibilities will be:
- You are responsible as Subject Matter Expert to support the application administrator of the relevant databases (e.g. LSS, COGNOS, Tableau, etc.)
- Optimize, define and implement business processes for processing of Individual Case Safety Reports regarding drug or medical device product
- You are responsible for the overview of user accounts of the IT systems used by Product Safety and initiating of corresponding maintenance and modification activities
- You will be responsible for computer system validation (CSV), activities Risk analysis, UAT's) and preparing and executing test scripts and initiating, executing and completing change control procedures.
- You initiate change controls with respect to changes in the relevant databases using e.g the JIRA management too
- You prepare, revise, review and train SOP's to the respective vigilance databases (e.g. LSS User Manual, LSS training)
- You prepare and support audits and inspections (creation of special reports) in the field of medical device vigilance
- You are responsible for concept development and management of projects for vigilance activities (e.g. outsourcing projects including commissioning and management of CROs/Service Provider)
- You are responsible for (Co-) Management of (sub)projects with respect to IT - system upgrades hot fixes and patches and implementation of change requests
What does this position offer you?
· Contract type: unlimited
· Vacation: 30 days / year
· Working time: 39 hours / week
· Benefits: company pension scheme according to internal company principles, seminars, language courses, health
care, leasing bicycles.
· Accessibility: very good transport connections
· Flexible work hours
· Attractive conditions and extensive social benefits
· Personal & professional development
- Scientific university degree combined with information technology knowledge
- Several years of experience in the field of medical device vigilance
- Sound knowledge of drug and medical device regulations (e.g. MPG, MDR, AMG, GVP)
- Knowledge in the processing of ICSRs and in medical coding Systems
- Sound knowledge and experience with (vigilance) databases
- A good knowledge of spoken and written English
- Capable of independent, analytical and conceptual work
Does this position sound interesting for you? Do not hesitate to contact me immediately.
Tel.: +49 89 2620 58 897