Safety Database Administrative Support

7 months ago

Markham, Canada Everest Clinical Research-Can Full time

Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.

Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest’s headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Bridgewater (Greater New York City Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China and Taipei, Taiwan.

Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success.

Quality is our backbone, customer-focus is our tradition, flexibility is our strength that’s us that’s Everest.

To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as Safety Database Administrative Support** **for our Toronto/Markham, Ontario, Canada on-site location, or remotely from a home-based office anywhere in Canada in accordance with our Work from Home policy.

**Job Accountabilities**:

- Conduct project specific configurations in Argus Safety for new clients, products, and studies in the development, validation, and production environments.
- Perform post go-live changes (database modifications) for existing studies based on required changes.
- Update and maintain the technical specifications documentation for Argus (Configuration Specifications Document [CSD]) for each new change control (new or updated configuration).
- Develop UAT scripts for new study builds or database modifications; lead the safety teams for UAT validation activities to maintain validation documentation in accordance with governing documents.
- Review the protocol and associated reference material and contribute to the development of the database development project timeline. Maintain database development timelines and promote good project management practices.
- Support initiatives for efficiencies in PV processes, including but not limited to, generation of autonarratives during case processing, standardized and custom reports from Argus or Argus Insight, and metric reports.
- Support Dictionary version management (MedDRA, WHO) and future database upgrade activities.
- Contribute to the preparation of documents such as status reports, data flow diagrams, SOPs, Work Instructions, training materials, and user manuals related to database development and administration.
- As needed, provide support to case processing of SAEs and/or pregnancy reports from clients’ ongoing drug clinical trials in a timely manner, including case triage, data entry, narrative writing, and quality review of cases processed by other team members.
- Ensure compliance with all applicable regulations and timelines for safety case processing and reporting.
- Act as a training resource to staff on case processing and the use of the Argus Safety System and associated case processing workflows.
- Keep current with industry best working practices in PV/MDV guidance(s) and regulatory requirements, industry trends, benchmarking, and best working practices in safety database development by reading and participating in relevant training, and/or related activities.

**Qualifications**:

- BS (or equivalent) degree in a life science or related field of study, or in computer science or information technology.
- One year experience working in a pharmaceutical or CRO environment is preferred.
- Prior technical background and experience with Oracle Argus Safety, including case processing and generating reports/line listings from the database, is an asset.
- Ability to work independently with little supervision; self-motivated and productive.
- Strong attention to detail.
- Excellent interpersonal and teamwork skills.
- Ability to maintain a high degree of confidentiality with clinical data and client’s proprietary data.
- Proven flexibility and adaptability when working in a team and independently, using good judgment in making decisions, is preferred.

We thank all interested applicants, however, only those selected for an interview will be contacted.

LI-Remote
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