Drug Safety Specialist
1 settimana fa
**Job Information**:
Industry
**Pharma**
***
Work Experience
**1-3 years**
***
City
**Roma**
***
Province
**Lazio**
***
Country
**Italy**
***
Postal Code
**00141**
***
**About us**:
- We are Business & Technology experts in the Life Science industry. We help companies to gain the best business value throught technology-enabled solutions.- With our business unit we provide Quality Compliance and Consulting services.
- PURPOSE:
- Performs in a timely, and accurate manner, case processing activities for the delivery of services to Clients, in full compliance with the applicable PV Legislation, Client’s requirements and the Regulatory Business Quality Standards.
**Requirements**:
- ACCOUNTABILITIES:
- To manage activities relating to the case processing: collection, processing, follow-up request, analysis, and distribution of adverse events (AEs)
- To perform scientific literature screening
- To ensure proper coding (MedDRA) into the applicable Safety Database
- To update the PV archive with the required documentation
- To assist in tracking cases to completion and adherence to processing timelines
- To assist in tracking compliance metrics
- To collaborate with supervisor in the preparation of the periodic safety reports as agreed with the client
- To follow applicable Standard Operating Procedures and working instructions for case processing
- PROFESSIONAL EXPERIENCE & BACKGROUND:
- University Degree in Scientific Subject
- At least 1 year in an equivalent position
- English, very goog
- Safety data management and safety database use
-
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