6 days old

Clinical Safety Advisor

MSC
Bethesda, MD 20814

Overview

Medical Science & Computing (MSC), a Dovel company, is an exciting growth oriented company, dedicated to providing mission critical scientific and technical services to the Federal Government. We have a distinguished history of supporting the National Institutes of Health (NIH) and other government agencies. MSC offers a dynamic and upbeat work environment, excellent benefits and career growth opportunities.

 

We attract the best people in the business with our competitive benefits package that includes medical, dental and vision coverage, 401k plan with employer contribution, paid holidays, vacation, Medical and Flexible Spending Accounts, Pre-Tax Transit Assistance and tuition reimbursement. If you enjoy being a part of a high performing, professional service and technology focused organization, please apply today!

 

Duties & Responsibilities

MSC is searching for a Clincial Safety Advisor to provide support to the National Institutes of Health (NIH). This opportunity is a full-time position with MSC and it is on-site in Bethesda, Maryland.

 

 

  • Ensure the most current domestic and international regulatory safety reporting requirements are used (e.g., ICH guidelines, FDA, EU and other national and international requirements).
  • Provide expert scientific and safety-related expertise to medical officers, study teams, and site investigators to include reviewing and providing comments to Division medical officers on protocols and working with Division medical officers to develop risk management/safety monitoring plans, as needed, for Division-supported studies.
  • Serve as a subject matter expert on the safety reporting needed for new Clinical Trial Agreements, safety data exchange agreements, clinical materials transfer agreements and Communication plans
  • Provide Expedited Adverse Event (EAE) reporting and safety management expertise and related safety support functions to include serving as a point of contact with project officers, contractors, grantees and intramural staff participating in both domestic and international studies and supporting the Divisions Adverse Experience Reporting System (DAERS).
  • Provide MedDRA coding expertise and support MedDRA-related activities.
  • Develop and/or review a variety of safety-related documents and training materials for use by the Division, its Clinical Research Organizations (CROs) and partners (e.g., policies, procedures, work instructions, guidance, and training materials related to safety monitoring and reporting requirements for Division-sponsored clinical trials).
  • Provide advice in matters related to safety and pharmacovigilance which includes developing pharmacovigilance practices such as set-up and configuration of the safety database, signal detection, trend analysis, analysis of aggregate safety and adverse event data to identify safety concerns in Division-supported clinical trials and provide expertise in preparing reports related to the manufacturing of investigational products such as development safety update reports (DSUR).

Requirements

  • Masters degree in Life Sciences, Public Health, or a related field.
  • Minimum of five (5) years of experience in safety reporting and policy.
  • Skilled in advising investigators and study teams on risk management and site monitoring plans.
  • Experience with Expedited Adverse Event Reporting (EAE) and advising scientific and clinical staff on various safety support functions.
  • Experience supporting MedDRA-related activities.
  • Advanced knowledge of Microsoft Office, Adobe Acrobat, and other document management systems.

 

 

Medical Science & Computing (MSC), a Dovel company, is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

Categories

Posted: 2020-05-19 Expires: 2020-06-18

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Clinical Safety Advisor

MSC
Bethesda, MD 20814

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