Global Medical Services
vor 4 Monaten
**Job Description Summary**: GE HealthCare’s Global Medical Services (GMS) organization includes the Global Pharmacovigilance and Medical Affairs groups in the Pharmaceutical Diagnostics (PDx) business. As a GMS Compliance and regional PV specialist, you will be part of the GMS Organization reporting into the Compliance and Training Function. You will actively contribute to the safety of our products on both a regional and global level.
At GE HealthCare, our machines, our software, our solutions, our services, and our people make a genuine difference to medical professionals and patients all over the world. That’s because we never lose sight of what healthcare really needs—the human touch.
**Your tasks include** (but are not limited to)**:
- You will set up and maintain efficient local pharmacovigilance (PV) systems in selected European countries in collaboration with Global PV and EUQPPV
- You act as deputy local PV contact person for local pharmacovigilance units in Europe, as needed
- You will perform collection, documentation, processing and following-up of local adverse events (AE) from all sources based on national legislation and internal procedures and submit ADR reports to Authorities in a timely manner, if applicable
- You take care of an adequate and timely reporting of local adverse events to the GEHC Central Safety Unit
- You will be maintaining a local training system for pharmacovigilance related tasks; this may include regional local PV training
- You will maintain a system for local literature searches (if applicable)
- You will be maintaining an archiving system for pharmacovigilance and safety related information
- You act as an interface between Sales, Customer Service teams & Global PV team in fulfilling local Pharmacovigilance related responsibilities (including training of local teams)
- You will monitor changes of local PV regulations, contribute to local signal detection and aggregate reports
- If applicable, you will maintain adequate regional PV Safety Data Exchange Agreements / Service Agreements with third parties
You will also support with GMS compliance and training governance activities such as:
- Quality Management System: Support creation, maintenance, review, and implementation of the local/regional/global PV related standard operating procedures. Furthermore, maintenance of a local Pharmacovigilance System Master File (PSMF) may be required.
- Support PV-audits and inspections, non-conformance, and CAPA-management
- Actively participate in departmental and various cross-functional project teams that may include Regulatory and Medical Affairs.
**Your profile**:
You bring...
- an Academic degree in sciences, pharmacy, or a medical degree
- proven experience in Regulatory and or Pharmacovigilance
- a strong self-motivation with the ability to multi-task with ability to prioritize, schedule and organize daily activities
- a knowledge and understanding of the pharmaceutical industry and strong knowledge of good vigilance practices
- a strong knowledge of EU-and local PV-legislation
- fluent German and English (written and spoken)
- the ability to communicate across all organizational levels and to set priorities and pivot as required
- a strong reliability and flexibility
- excellent communication skills
- the willingness to travel occasionally, especially in Germany, Austria and Switzerland
**About GE HealthCare**:
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
GE HealthCare - Creating a world where healthcare has no limits
LI-KRONE
LI-HYBRID
**Additional Information**:
**Relocation Assistance Provided**:No
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