Experience

Actelion (now Janssen Pulmonary Hypertension)

• Switzerland
• Pharmaceutical Manufacturing
• 500 - 600 Employee

• Drug Safety Case Manager

  • Nov 2008 - Present

  Review contents of adverse events (AEs) received from Solicited and Spontaneous sources • Process AEs: enter into Argus database, request follow-up information by fax or calls to prescribers • Assess AEs for regulatory reporting and process cases on time to meet reporting /submission timelines • Member of MedDRA coding team: participate in writing/review of Coding Manual, Review coding with co-workers, bring issues to MedDRA team for resolution Review contents of adverse events (AEs) received from Solicited and Spontaneous sources • Process AEs: enter into Argus database, request follow-up information by fax or calls to prescribers • Assess AEs for regulatory reporting and process cases on time to meet reporting /submission timelines • Member of MedDRA coding team: participate in writing/review of Coding Manual, Review coding with co-workers, bring issues to MedDRA team for resolution



bayhill therapeutics

• Sr. CRA/Clinical Trial Manager

  • Nov 2006 - Nov 2008

  Monitoring and close-out for several phase I studies. Worked with CRO for international phase II study With lab CRO person: Set-up lab supply distribution for sites, scheduled over a year to meet needs for lab kits Organized close-out activities with CRO to get sites monitored, tests performed and close-out complete and drug destroyed. Collected all regulatory documents (international) for study start and close-out. Reviewed protocols, CRFs, consents and collected study documents Wrote safety sections of SAEs for study reports Reviewed CRFs and site monitoring reports of CRAs working for CRO Performed initiation training for international CRAs via phone



Johnson & Johnson

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Sr Drug Safety Associate

  • Feb 2003 - Aug 2006



CV Therapeutics

• Biotechnology Research
• 100 - 200 Employee

• Drug Safety Associate

  • Jan 2002 - Jan 2003



CCS Associates, Inc.

• United States
• Research
• 1 - 100 Employee

• Sr CRA

  • Jun 1997 - Jan 2002

  initiate, monitor and close-out of phase 1 & 2 Chemo-prevention clinical trials. Assist sites with protocol writing, CRF design, study-related questions initiate, monitor and close-out of phase 1 & 2 Chemo-prevention clinical trials. Assist sites with protocol writing, CRF design, study-related questions



Roche

• Switzerland
• Biotechnology Research
• 700 & Above Employee

• Safety CRA

  • Feb 1996 - Jun 1997

  Clinical Trial safety reports, clinical-safety database reconciliation Clinical Trial safety reports, clinical-safety database reconciliation



Collagen Corp

• Medical Device Safety Associate

  • Jun 1993 - Jun 1995



syntex

• drug safety associate

  • 1989 - 1993

  Post-marketing and clinical trial case processing of adverse event reports Received reports via phone, provided PI information, requested follow-up Performed database searches to provide requested information for physicians and pharmacists and provided them with information from searches Post-marketing and clinical trial case processing of adverse event reports Received reports via phone, provided PI information, requested follow-up Performed database searches to provide requested information for physicians and pharmacists and provided them with information from searches