Pharmacovigilance Scientist Resume Cincinnati, OH - Hire IT People

SUMMARY

Dynamic and effective professional wif a strong background and three years of experience in the field of drug safety.

TECHNICAL SKILLS

Computer Skills: Microsoft Word, Excel, PowerPoint, Outlook; Mac OS X; Windows, ARISg database 6.6.2.4.2

PROFESSIONAL EXPERIENCE

Confidential, Cincinnati, OH

Pharmacovigilance Scientist

Responsibilities:

Processing of adverse event cases using ARISg and IRT applications in oncology and E2b workflows for the third largest pharmaceutical company worldwide (Roche).
Writing narratives for ICSRs, which can be spontaneous, clinical or literature cases.
Provide clinical research and time - sensitive assessment ensuring regulatory compliance.
Quality assessment of case reports for seriousness, causality and expectedness of adverse events adhering to SOP, GCP and regulatory requirements.
Performed MedDRA and WHO DD coding.
Assisted wif E2B database migration using ARISg and IRT applications for InterMune drug safety.
Contribute to pharmacovigilance physician and safety scientist team, which are set up to discuss signal management and risk management matters.
Comprehensive knowledge of international drug safety, pharmacovigilance principals and regulations.
Developing and maintaining knowledge of different diseases, therapeutic areas and associated drugs.
Understanding of internal resources such as Investigator's Brochure (IB), core safety information, data handling guidelines and study protocols.

Confidential, Cincinnati, OH

Lab Research Assistant

Responsibilities:

Performed various laboratory techniques such as slides preparation, spectrophotometer, chromatography, bacteria culturing, autoclave, bacteria media, extraction/purification of DNA, streak plates, traditional PCR, qPCR, master mix preparation, electrophoresis, gel documentation, pipette, mettler balance, pH meter, scanning electron microscope, inverted microscope, and transmission electron microscope.
Used proper aseptic techniques.
Collaborated and communicated in a team effectively to meet multiple daily goals.
Collected, recorded and reported lab data accurately.