Pharmacovigilance Quality Specialist (m/w/d)

Pharmacovigilance Quality Specialist (m/w/d), Vienna

Client:

Experis ManpowerGroup

Location:

Vienna

Job Category:

Other

EU work permit required:

Yes

Job Reference:

4d9120e9429a

Job Views:

2

Posted:

19.04.2025

Expiry Date:

03.06.2025

Job Description:

For one of our clients, a renowned pharma company based in Vienna, we are currently filling the position as a

Pharmacovigilance Quality Specialist (m/w/d)

Your tasks:

1. Maintenance and development of the drug safety SOP system
2. Assistance in the implementation and maintenance of a comprehensive GVP compliant quality program
3. Support the initiation, writing, review, approval, update, and distribution of documents e.g. policies, SOPs, and associated documents
4. Maintenance and development of the drug safety training system
5. Maintenance and development of the drug safety deviation management system and CAPA plan
6. Training and ongoing qualification of local drug safety personnel
7. Management of external safety relevant network
8. Compliance and deviation management of the drug safety system
9. Development and maintenance of the Pharmacovigilance System Master File
10. Preparation, execution, post-processing of authority PV inspections, preparation of inspection report and coordination of action plans
11. Planning, conduct and follow up of drug safety audits

Your profile:

1. Completed academic degree, ideally in a medical, life science or healthcare discipline
2. Pharmacovigilance knowledge and experience in quality assurance related to drug safety would be an advantage
3. Working knowledge of GVP, GCP and ICH and how they interface with other GxPs
4. Very good verbal and written English skills as well as communication and presentation skills
5. Team player with a strong focus on timelines
6. Good level of computer literacy, in particular in the use of databases
7. Commitment and ability to handle high workloads and deadlines
8. High degree of accuracy with attention to detail
9. Excellent critical, analytical and problem-solving skills

We offer:

1. Wide range of tasks in an international setting, flexibility and personal responsibility
2. Reliable employer with generous employee benefits and a salary customary in the market.
3. Familiar setting of a family-owned enterprise with benefits such as staff restaurant, extraordinary staff events and many more.

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