Kathleen O'hara kathleen.ohara@bayer.com & | • Processed clinical trial and spontaneous serious adverse event (SAE) and adverse event (AE) reports received according to International Conference on Harmonization-Good Clinical Practice (ICH-GCP) guidelines, regulatory requirements, and company standard operating procedures (SOPs) • Used knowledge of Food and Drug Administration (FDA) and ICH guidelines and product labeling in performing initial case assessment for seriousness and/or expectedness/listedness • Evaluated and assessed incoming case reports and source documentation for completeness, accuracy, legibility, and consistency of information and implemented drafting of SAE/AE initial and follow-up narratives • Communicated with partner companies, collaborative sponsors and respective clinical research organizations (CROs) regarding evaluation and processing of case reports • Coded adverse event terminology, medical information, and drug information in Pharmacovigilance database utilizing MedDRA and WHO-Drug dictionaries • Determined necessary follow-up for missing, discrepant or additional information/source documentation for each case using medical, product and regulatory knowledge and ensured required follow-up information to completion • Performed quarterly literature review of applicable products and ensured required literature cases were processed within the Pharmacovigilance database • Created and maintained electronic and hard copy case files per company SOPs • Assisted with the maintenance of the Pharmacovigilance database, including participation in validation and implementation activities for system upgrades and maintenance of the database user manual • Assisted in the development, maintenance, and training of departmental SOPs, policies, and implementation guidelines • Completed all work within acceptable quality standards and determined timelines • Attended regularly scheduled PV Ops meetings as required • Participated in appropriate training pertinent to job performance as required

Kathleen O'hara

• Processed clinical trial and spontaneous serious adverse event (SAE) and adverse event (AE) reports received according to...

Rutherford, New Jersey, United States

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Kathleen O'hara’s Emails [email protected]

Kathleen O'hara’s Phone Numbers No phone number available.

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Kathleen O'hara’s Location Rutherford, New Jersey, United States

Kathleen O'hara’s Expertise • Processed clinical trial and spontaneous serious adverse event (SAE) and adverse event (AE) reports received according to International Conference on Harmonization-Good Clinical Practice (ICH-GCP) guidelines, regulatory requirements, and company standard operating procedures (SOPs) • Used knowledge of Food and Drug Administration (FDA) and ICH guidelines and product labeling in performing initial case assessment for seriousness and/or expectedness/listedness • Evaluated and assessed incoming case reports and source documentation for completeness, accuracy, legibility, and consistency of information and implemented drafting of SAE/AE initial and follow-up narratives • Communicated with partner companies, collaborative sponsors and respective clinical research organizations (CROs) regarding evaluation and processing of case reports • Coded adverse event terminology, medical information, and drug information in Pharmacovigilance database utilizing MedDRA and WHO-Drug dictionaries • Determined necessary follow-up for missing, discrepant or additional information/source documentation for each case using medical, product and regulatory knowledge and ensured required follow-up information to completion • Performed quarterly literature review of applicable products and ensured required literature cases were processed within the Pharmacovigilance database • Created and maintained electronic and hard copy case files per company SOPs • Assisted with the maintenance of the Pharmacovigilance database, including participation in validation and implementation activities for system upgrades and maintenance of the database user manual • Assisted in the development, maintenance, and training of departmental SOPs, policies, and implementation guidelines • Completed all work within acceptable quality standards and determined timelines • Attended regularly scheduled PV Ops meetings as required • Participated in appropriate training pertinent to job performance as required

Kathleen O'hara’s Current Industry Bayer

Kathleen O'hara’s Prior Industry
Metropolitan Research Associates | Merckschering Plough | Regeneron Pharmaceuticals | Bayer

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Work Experience

Bayer

Pharmacovigilance Case Specialist, Oncology

Mon Apr 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time) — Present

Regeneron Pharmaceuticals

Drug Safety Specialist

Mon Nov 01 2010 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Mar 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time)

Merckschering Plough

Drug Safety Specialist

Thu Nov 01 2007 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Jul 01 2010 00:00:00 GMT+0000 (Coordinated Universal Time)

Metropolitan Research Associates

Drug Safety Associate

Wed Nov 01 2006 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Nov 01 2007 00:00:00 GMT+0000 (Coordinated Universal Time)

Skills

Languages

FAQ About Kathleen O'hara

Kathleen O'hara is located at
Rutherford, New Jersey, United States

Kathleen O'hara is a
• Processed clinical trial and spontaneous serious adverse event (SAE) and adverse event (AE) reports received according to International Conference on Harmonization-Good Clinical Practice (ICH-GCP) guidelines, regulatory requirements, and company standard operating procedures (SOPs) • Used knowledge of Food and Drug Administration (FDA) and ICH guidelines and product labeling in performing initial case assessment for seriousness and/or expectedness/listedness • Evaluated and assessed incoming case reports and source documentation for completeness, accuracy, legibility, and consistency of information and implemented drafting of SAE/AE initial and follow-up narratives • Communicated with partner companies, collaborative sponsors and respective clinical research organizations (CROs) regarding evaluation and processing of case reports • Coded adverse event terminology, medical information, and drug information in Pharmacovigilance database utilizing MedDRA and WHO-Drug dictionaries • Determined necessary follow-up for missing, discrepant or additional information/source documentation for each case using medical, product and regulatory knowledge and ensured required follow-up information to completion • Performed quarterly literature review of applicable products and ensured required literature cases were processed within the Pharmacovigilance database • Created and maintained electronic and hard copy case files per company SOPs • Assisted with the maintenance of the Pharmacovigilance database, including participation in validation and implementation activities for system upgrades and maintenance of the database user manual • Assisted in the development, maintenance, and training of departmental SOPs, policies, and implementation guidelines • Completed all work within acceptable quality standards and determined timelines • Attended regularly scheduled PV Ops meetings as required • Participated in appropriate training pertinent to job performance as required Bayer

Kathleen O'hara currently works in the
Bayer

Kathleen O'hara specializes in
• Processed clinical trial and spontaneous serious adverse event (SAE) and adverse event (AE) reports received according to International Conference on Harmonization-Good Clinical Practice (ICH-GCP) guidelines, regulatory requirements, and company standard operating procedures (SOPs) • Used knowledge of Food and Drug Administration (FDA) and ICH guidelines and product labeling in performing initial case assessment for seriousness and/or expectedness/listedness • Evaluated and assessed incoming case reports and source documentation for completeness, accuracy, legibility, and consistency of information and implemented drafting of SAE/AE initial and follow-up narratives • Communicated with partner companies, collaborative sponsors and respective clinical research organizations (CROs) regarding evaluation and processing of case reports • Coded adverse event terminology, medical information, and drug information in Pharmacovigilance database utilizing MedDRA and WHO-Drug dictionaries • Determined necessary follow-up for missing, discrepant or additional information/source documentation for each case using medical, product and regulatory knowledge and ensured required follow-up information to completion • Performed quarterly literature review of applicable products and ensured required literature cases were processed within the Pharmacovigilance database • Created and maintained electronic and hard copy case files per company SOPs • Assisted with the maintenance of the Pharmacovigilance database, including participation in validation and implementation activities for system upgrades and maintenance of the database user manual • Assisted in the development, maintenance, and training of departmental SOPs, policies, and implementation guidelines • Completed all work within acceptable quality standards and determined timelines • Attended regularly scheduled PV Ops meetings as required • Participated in appropriate training pertinent to job performance as required

Kathleen O'hara speaks the following languages:
No languages available.

Kathleen O'hara has prior experience in the following industries:
Regeneron Pharmaceuticals , Merckschering Plough , Metropolitan Research Associates

Kathleen O'hara has the following professional experience:
Bayer , Regeneron Pharmaceuticals , Merckschering Plough , Metropolitan Research Associates .