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Jenny Wakker
4509 West Ridge RD,
Erie, PA, 16506
(814) 836 - 9640
OBJECTIVE
To utilize my knowledge effectively in the better environment and to secure my position in biotech environment.
PROFESSIONAL EXPERIENCE
(1995 - Present) BIOGEN IDEC, INC., Cambridge, Massachusetts
Research Associate
- Maintain current knowledge of global regulations with respect to safety reporting and pharmacovigilance.
- Provide support to global staff regarding global safety policies, processes and procedures.
- Ensure regulatory conformity for expedited submission of case reports.
(1994 - 1995) ABRAXIS BIOSCIENCE, Los Angels, CA
Drug Safety Scientist
- Involved in drug safety data management, including the evaluation of individual clinical trial or post-marketing pharmacovigilance reports and writing case narratives.
- Established causality assessments, classify and identify adverse events, apply for medically relevant follow-up information and review information entered into the safety database.
- Literature review, preparation and write of safety updates or reports, and answer the queries from regulatory authorities.
EDUCATION
(May - 1993) STEPHEN F. AUSTIN STATE UNIVETSITY, Nacogdoches, TX
MS in Biotechnology
CERTIFICATION
- Adverse Drug Events - Understanding and Reporting Requirements
- Army Medical Laboratory Technician Course
- The EU Clinical Trial Directive