Drug Safety Specialist Lazio

Drug Safety Specialist
Roma
Lazio, Lazio

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