Safety Specialist III - Quality Management


Posted 83 days ago

Salary: Not Disclosed

Safety Specialist III - Quality Management

Ref #: 26770

Employment type: Permanent - Full-Time

Location: Cambridge

Posted: 05-Feb-2021


Roles & Responsibilities of the position:

The Service Provider will perform QC of the data entry against source documentation, and will assess the case for completeness, accuracy and compliance with our clients data entry conventions as specified in our clients SOPs and/or Process Documents.

•Case QC will be documented within the Global Safety Database with date of QC, and identifiers of the person that completed the QC and the person who processed the case

•QC feedback will be provided to the person that processed the case via the Global Safety Database to ensure correct data entry conventions are reinforced

•Case QC must be completed within the agreed timelines

•Case QC will include 100% quality checks of key defined data fields and narratives for defined cases, as agreed with our clients

•Quality check requirements will be reviewed by our clients periodically and may be revised during the project. The Service Provider will maintain appropriate records and audit trails of all ICSR related documents and associated QC/QA checks

Quality Management activities will also include retrospective reviews of a subset of cases.

•The Service Provider will action any data requests for clarification or correction based on retrospective QC or compliance report checks performed by our clients.

•The Service Provider will be responsible for responding to and performing any case correction as needed resulting from these QC reviews. our client performs internal, retrospective QC checks of ICSRs. The findings are presented in the form of line listings, and are expected to be corrected within a specified amount of time

Quality Management activities will also include analysis of collated QC data.

•Collated QC data are reviewed monthly to provide oversight of individual Case Processors’ quality and quarterly to identify trends in errors and take corrective and preventative action as necessary

•Corrective and preventative action may include development and delivery of training to relevant Operations staff on data e

Job Requirements

•Safety Specialist who will be performing ICSR Quality Management must have all of the above criteria for a Safety Specialist plus:

•Healthcare professional (e.g. RN, Pharmacist, etc.)

•Minimum of 2-3 years’ experience in Pharmacovigilance including ICSR processing

•Excellent database and coding skills (experience with MedDRA)

•Argus knowledge preferred

•Previous ICSR QC experience preferred

Remuneration & other details

•Competitive salary

•Office based – Cambridge

•Permanent Position


DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.

More jobs at DOCS

Study Biostatistician / Senior Biostatistician


Salary: Not Disclosed

Posted 83 days ago

Global Trial Leader

DOCS - Austin, Texas, United States

Salary: Not Disclosed

Posted 83 days ago

Senior Clinical Research Associate

DOCS - Texas, United States

Salary: Not Disclosed

Posted 83 days ago
See all jobs at DOCS