Shayna Booker

City, State, Zip Code

Home: 000-000-0000 | Cell: 000-000-0000

email@email.com

Summary

Analytical and results-oriented Drug Safety Associate with over 10 years’ experience collaborating as a strong team player to uncover and address pharmaceutical safety issues. Great communication organization and time management abilities.

Highlights
  • Documentation
  • Medical terminology
  • WHO Drug Dictionary
  • cGXPs knowledge
  • Leadership skills
  • FDA and ICH guidelines
  • Case management
  • Reporting and analysis
  • Exceptional research abilities
  • Project coordination
Experience
Drug Safety Associate
11/1/2010 – Current
Company Name
City, State
  • Research consumer responses and safety reports on products.
  • Investigate over 100 claims each month.
  • Collaborate with team of investigators and product managers to collect evidence.
  • Work with management to prepare reports and submit to regulators.
  • Complete documentation for all investigations.
Drug Safety Association
6/1/2007 – 10/1/2010
Company Name
City, State
  • Identified and researched product safety reports.
  • Contacted consumers and health professionals regarding incidents.
  • Made timely reports to regulatory authorities.
  • Prepared reports and presentations to inform decision-making.
  • Maintained comprehensive clinical database for team.
Drug Safety Associate
5/1/2004 – 5/1/2007
Company Name
City, State
  • Followed up with regulators colleagues and consumers on safety issue reports.
  • Drafted reports of safety findings and prepared presentations for management.
  • Evaluated incidents and collected further information.
  • Documented all findings in computer database system.
  • Utilized extensive regulatory and medical knowledge to assess claims.
Education
Bachelor of Science – Nursing
XXXX – XXXX
University of Oklahoma
City, State

Graduated with Honors

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