Job perspectives

Drug Safety Officer

Drug safety officers are responsible for documenting, reporting, tracking and evaluating adverse events pertaining to medical products. The work of a drug safety officer has to be done in compliance with national and international regulations.


Duties

Processing of adverse events
Creating Periodic Safety Update Reports
Data entry of adverse drug reactions
Analysis of drug risks
Risk-benefit assessment of drugs
Creating information sheets for doctors, pharmacist, patients
Support for clinical trials

Clinical Trials Specialist

Clinical trials specialists work in clinical research. They support the organization and development of clinical trials according to international guidelines and national laws. They work as a Clinical Research Associate (CRA) and/or a Data Manager.

Clinical Research Associates are responsible for supporting and monitoring the study centers/sites. They also stay in constant communication with the investigator and their team. Another important aspect of a CRAs work is to ensure the quality of all collected data and to check adherence to the study protocol. The required travel time of a CRA is usually 50% to 75% of their working hours. Another key area is the documentation of all relevant data and the CRA has to communicate, clarify and possibly track any complaints or questions that have arisen throughout a clinical trial.


Duties of a CRA

Responsible for training and supporting the team members on site
Guarantee compliances with laws, guidelines, and study protocol
Comparison of collected data with source data
Ensuring site has adequate resources to conduct a study
Writing reports of site visits (documentation)
Tracking and clarifying complaints
Intermediary between sponsor, study center/site, and other parties

Data Managers are responsible for processing all relevant study data. In clinical trials it is standard to collect such data with the use of case report forms, specialized medical print-outs and patient diaries. The data will be entered in a preprogrammed database which checks for discrepancies and allows for corrections if necessary. As a consequence the compared and validated data is available for statistic evaluation.


Duties of Data Manager

Development of Case Report Forms (questionnaire)
Programming of query
Plausibility checks
Issue list of faulty data and queries
Coding of data
SAE Reconciliation
Documentation of data movements and data handling

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