Open to opportunities

Brenda CJ

@brendacj

Seasoned professional in clinical nursing & pharmacovigilance. Specializes in remote medical device roles, pharma, remediation, and audit resolutions.

United States

Message

What I'm looking for

I seek roles in post-market safety or pharmacovigilance where I can apply regulatory expertise, lead complaint handling, mentor teams, and improve quality and compliance within a collaborative, process-driven organization.

I am a seasoned professional with a robust background in both clinical nursing and pharmacovigilance. My acute care experience is broad, covering areas from oncology and pediatrics to medical-surgical and psychiatry. Since moving into the pharmaceutical and medical device sectors in the early 2000s, I have actively contributed to the development and diversification of pharmacovigilance systems. Most recently, my focus over the past six years has been as a remote medical device professional, specializing in helping companies manage combination product pipelines, navigate remediation processes, and successfully resolve audit findings and FDA Form 483 observations.

Experience

Work history, roles, and key accomplishments

Current

Combination Product Clinician

Current

Pfizer

Jul 2020 - Present (5 years 4 months)

Led complaint review and investigations for combination product medical devices, ensuring MDR/MDV compliance and closing cases with documented rationale while coordinating cross-functional investigations across manufacturing and safety.

Complaint Handling Risk Assessment Argus Regulatory Compliance Clinical Documentation

Postmarket Surveillance Consultant

E. G. Life Sciences

May 2019 - May 2020 (1 year)

Supported post-market surveillance and quality tasks, remediated 6,000 records for reportability and coding, and filed service reports to ensure regulatory compliance and accurate safety data.

Quality Assurance Coding

Customer Quality Analyst III

DePuy Synthes

Mar 2014 - Nov 2018 (4 years 8 months)

Supported post-market regulatory affairs and complaint handling including MDR submissions, non-conformance investigations, field actions, and documentation management to support complaint processing and closure.

MDR Complaint Handling Documentation Management Metrics

Drug Safety Associate

Research Pharmaceutical Services

Apr 2013 - Mar 2014 (11 months)

Performed triage and case-level review of serious adverse events and spontaneous reports, conducted data entry and coding in MedDRA, and assisted with regulatory submissions and safety management.

MedDRA Case Processing Regulatory Submissions Safety Database Management

Adverse Event Coordinator III

Joule, Inc.

Aug 2012 - Apr 2013 (8 months)

Reviewed and processed domestic and non-domestic adverse event reports per SOPs and FDA regulations, determining periodic classifications and ensuring completeness for marketed and investigational products.

FDA Regulation Domestic And International AE Handling Safety Reporting Documentation

Safety Surveillance Associate

Pfizer

Jul 2011 - Jun 2012 (11 months)

Supported review and assessment of clinical trial and post-marketing adverse event reports to determine regulatory reporting requirements and seriousness pursuant to labeling and global guidelines.

Regulatory Reporting

Drug Safety Associate

Smith-Hanley

Jun 2010 - Jun 2011 (1 year)

Conducted clinical assessment and processing of reported adverse drug experiences, maintained safety database accuracy, and determined regulatory reporting requirements per guidelines and product labeling.

Clinical Assessment Regulatory Reporting Data Quality

Drug Safety Associate

Yoh Scientifics

Feb 2010 - May 2010 (3 months)

Collected and assessed adverse event information, created reports in the drug safety database for FDA submission, and ensured timely reporting in accordance with global drug safety procedures.

Initial Assessment Pharmacovigilance