Team Leader Duties

 

Planned, assigned, and directed the work of team members in conducting drug safety evaluations to assess post-market product risks:

  • Assigned work based upon priorities, consideration of difficulty and requirements of assignments, and the capabilities of team members
  • Allocated and adjusted resources in response to workload and priority changes
  • Evaluated work products qualitatively and quantitatively
  • Recommended performance rating for team members
  • Explored approaches to improve production and increase quality of the work products of team members
  • Worked on the resolution of workplace conflicts at the earliest stage

Mentored and trained team members; personally explained critical clinical and epidemiologic concepts as well as regulatory and compliance concepts.

Assessed team members’ individual developmental needs and provided them with developmental opportunities.

Evaluated industry generated safety reports, research summaries, and studies

Analyzed electronic medical record data licensed for use by the Agency. Led analytic epidemiologic study teams conducting research projects using these data to address drug safety concerns initiated by the Office or in response to drug safety consults from other CDER Divisions.

Served as the principal scientific advisor to the Division Director, Office Director, and other Center managers with regard to the use and interpretation of electronic medical record data licensed for use by the Agency to evaluate important drug safety issues.

Played a leadership role in resolving complex, long-range, and emerging problems in drug safety and epidemiology; kept abreast of crucial safety issues under review in the Division and briefed the Division Director and Office managers on medical and epidemiological interpretations and analyses of drug safety data.

Planed, coordinated, and evaluated programs and activities of the Division regarding epidemiology and risk assessment/ management.

Established methodologies, procedures, standards, guidelines, and policies for analysis of electronic medical record data and other epidemiological data.

Interacted with private and public entities outside of FDA in relation to the use of electronic medical record data in drug safety and other epidemiological data that are relevant to the Division’s mission.

Severed as a Project Officer for extramural research contracts.

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