Bonnie King, BSN, RN, CMC
Durham,NC
Summary
Pharmacovigilance leader with extensive Sponsor and CRO experience including but not limited to vendor oversight, MedDRA and WHODrug coding review, aggregate and signal detection report review and oversight, case processing, ICSR submissions, and more. I'm an organized and detail-oriented candidate successful at managing multiple priorities with a positive attitude and willingness to take on added responsibilities to meet team goals.
Overview
30
30
years of professional experience
1
1
Certification
Work History
Senior Clinical Safety Scientist
HiberCell, Inc
12.2022 - Current
- Provide oversight management of safety CRO for all aspects of SAE processing and provide training and guidance
- Serve as Subject Matter Expert for pharmacovigilance
- Collaborate with Medical Directors, Clinical Operations, Project Managers, Data Management, Regulatory, and clinical CRO for multiple studies
- Provide SAE support to clinical study sites
- Review all MedDRA and WHODrug coding monthly
- Review and provide input on DSUR, CSR, IB, Protocol, and Signal Reports
- Assist with SAE reconciliation
- Review relevant data in clinical database for data cleaning
- Write patient safety narratives for CSR
- Review and write SOPs
- Review and write Technical Agreements and Pharmacovigilance Agreements
- Provide safety data for company-wide presentations.
Consultant
Safe Harbor Pharmacovigilance, LLC
04.2018 - 12.2022
- Review coding for WHODrug and MedDRA for multiple studies
- Provide pharmacovigilance support and ICSR processing duties
- Perform QA of narratives and data entry for processed cases
- Perform triage, site queries, and collaborate with medical monitors and other safety team colleagues.
Drug Safety Consultant/Senior Clinical Safety Specialist
Drug Safety Solutions/ProPharma Group
10.2016 - 04.2018
- Responsible for all aspects of Phase I - Phase 3 clinical study pharmacovigilance (PV) processing of Serious Adverse Events (SAEs) including composing narratives, data entry into safety database, querying sites, performing reconciliation, and communicating with physicians, sponsors and other study personnel
- Designed forms, templates, and Safety Management Plans for new studies
- Responsible for submitting SUSAR reports to global regulatory authorities.
Case Manager II
Ashfield Pharmacovigilance
06.2016 - 09.2016
- Responsible for high-volume post-marketing PV activities including case processing, QC, and following up on serious and non-serious adverse events (AEs) submitted by spontaneous reports and literature searches
- Responsible for generating monthly aggregate reports and providing client support
Clinical Safety Scientist
Glaxo Smith Kline
11.2013 - 08.2014
- Responsible for processing, collecting and analyzing SAEs and pregnancy reports from clinical trial reports, including composing narratives, generating site queries, and coding information in MedDRA.
Contract Medical Data Reviewer
UCB Pharma
11.2010 - 03.2012
- Responsible for data cleaning of all Clinical Trial Data for subjects enrolled in sponsored clinical trials
- Responsible for identifying missing or inconsistent data and generating queries in clinical database for Study Physician review
Senior Product Safety Scientist
RHO, Inc
10.2009 - 11.2010
- Responsible for collecting, monitoring, processing, and distributing SAE reports
- Assists with SAE reconciliation between the safety and clinical databases.
Drug Safety Associate
PAREXEL International
12.2008 - 10.2009
- Responsible for clinical safety SAE narratives, data entry into safety database, query development, and closing cases
- Responsible for updating SAE procedures, SMP, forms, and guidelines
Legal Nurse Consultant
Lewis-Roberts, PLLC
10.2006 - 05.2008
- Reviewed medical records for pertinent data and composed chronologies and narratives for pharmaceutical litigation
Drug Safety Associate, II
Drug Safety Alliance, Inc
09.2004 - 10.2006
- Responsible for post-marketing safety projects with marketed pharmaceutical products involved in class-action litigation and targeted investigation of adverse events of special interest
- Responsible for collection, processing, follow-up, analysis, and regulatory reporting of events for marketed products and investigational compounds.
Registered Nurse
Varied
01.1994 - 01.2001
- From January 1994 to January 2001,I worked as an RN in a variety of clinical settings including women's health, pediatrics, surgery/oncology, and management
Education
Bachelor of Science - Nursing
Rutgers, The State University of New Jersey
Camden06.1996
Skills
- Vendor management
- Subject Matter Expert in Pharmacovigilance
- Aggregate report review
- Signal detection report review
- PV sections of IB, RSI, and Protocol updates
- Certified MedDRA coder
- Argus, ARISg, Medidata, MedDRA, WHODrug
- Wide variety of therapeutic areas
- Excellent communication and collaborative teamwork
Certification
- Licensed Registered Nurse North Carolina, #151076
- Certified MedDRA Coder: 2022 (active)
Timeline
Senior Clinical Safety Scientist
HiberCell, Inc
12.2022 - Current
Consultant
Safe Harbor Pharmacovigilance, LLC
04.2018 - 12.2022
Drug Safety Consultant/Senior Clinical Safety Specialist
Drug Safety Solutions/ProPharma Group
10.2016 - 04.2018
Case Manager II
Ashfield Pharmacovigilance
06.2016 - 09.2016
Clinical Safety Scientist
Glaxo Smith Kline
11.2013 - 08.2014
Contract Medical Data Reviewer
UCB Pharma
11.2010 - 03.2012
Senior Product Safety Scientist
RHO, Inc
10.2009 - 11.2010
Drug Safety Associate
PAREXEL International
12.2008 - 10.2009
Legal Nurse Consultant
Lewis-Roberts, PLLC
10.2006 - 05.2008
Drug Safety Associate, II
Drug Safety Alliance, Inc
09.2004 - 10.2006
Registered Nurse
Varied
01.1994 - 01.2001
Bachelor of Science - Nursing
Rutgers, The State University of New Jersey
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