Position Objective: Provide services as a Clinical Advisor in support of the overall functions of the Safety and Pharmacovigilance Team in the Office for Policy in Clinical Research Operations, Division of AIDS (DAIDS) within the National Institute of Allergy and Infectious Diseases (NIAID).

Duties and Responsibilities:

• 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 DAIDS medical officers on protocols and working with DAIDS medical officers to develop risk management/safety monitoring plans, as needed, for DAIDS-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 DAIDS 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 DAIDS, its CROs and partners (e.g., policies, procedures, work instructions, guidance, and training materials related to safety monitoring and reporting requirements for DAIDS-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).

  Basic Qualifications:

• Minimum of a M.D. or Masters degree in health related field and 10 years of experience is required.

  Minimum Qualifications:

• Ability to communicate effectively, orally and in writing, with non-technical and technical staff.

• Detail-oriented and possess strong organizational skills with the ability to prioritize multiple tasks and projects

  *This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required by this position.

  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  GAP Solutions provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job, email us at recruiting@gapsi.com . You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned.

  GAP Solutions is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to their race, ethnicity, ancestry, color, sex, religion, creed, age, national origin, citizenship status, disability, medical condition, military and veteran status, marital status, sexual orientation or perceived sexual orientation, gender, gender identity, and gender expression, familial status, political affiliation, genetic information, or any other legally protected status or characteristics.

  This position is contingent upon contract award.

Requisition ID: 7069