Latoya M. Gatling
Pharmacovigilance Manager, Oncology biotechnology
Cambridge, MA · (617) 555 0145 · name@example.com · linkedin.com/in/latoyamgatling
Key Qualifications
EXPERIENCE
Eleven years in drug safety, five of them managing case processing teams
INDUSTRIES
Oncology biotechnology, contract safety services
SPECIALTIES
Case intake and triage, expedited reporting, aggregate report authoring, inspection readiness
SYSTEMS
Argus Safety, Veeva Vault, TrackWise, Medical Dictionary for Regulatory Activities browser
CREDENTIALS
Regulatory Affairs Certification, 2020
EDUCATION
Master of Science in pharmacology, Boston University
Executive Summary
Pharmacovigilance manager running case processing and expedited reporting for an oncology portfolio at a mid size biotechnology company. Leads a team of 12, owns the compliance number the executive team sees every month and has taken the group through one inspection without a single observation on safety.
Signature Achievements
- Held expedited fifteen day reporting compliance at 99.6 percent across 2,400 cases in the last two years.
- Took the safety group through a Food and Drug Administration inspection with no observations raised on pharmacovigilance.
- Cut average case processing time from nine days to five by rebalancing triage against medical review.
- Rebuilt the periodic safety update report timeline so the last four submissions went out ahead of the due date.
- Grew and trained a team from seven to 12 case processors with no loss of quality score during the ramp.
- Closed 18 corrective and preventive action items from an internal audit inside the agreed 90 day window.
Professional Experience
Pharmacovigilance Manager
Charles Basin Oncology, Cambridge, MA 2021 to present
Leads a 12 person case processing and reporting team covering two marketed oncology products and four studies.
- Owns intake, triage and submission of adverse event cases including MedWatch reporting to the Food and Drug Administration.
- Reviews expedited fifteen day reports before release and holds the monthly compliance metric for the leadership meeting.
- Authors and reviews periodic safety update reports and supports the signal detection meeting with case listings.
- Manages deviations and corrective and preventive action records in TrackWise and closes them to schedule.
- Runs inspection readiness reviews of standard operating procedures, training records and case files twice a year.
- Represents safety at the product quality complaint review so paired complaints and events stay linked.
Senior Drug Safety Associate
Merrimack Safety Partners, Waltham, MA 2016 to 2021
Case processing and quality review at a contract safety provider serving eight sponsor companies.
- Processed and coded serious adverse event cases in Argus Safety for clinical and postmarketing sources.
- Performed quality review on 40 cases a month and fed error trends into processor retraining.
- Wrote safety data exchange agreement summaries for two new sponsor accounts.
- Trained six new associates on intake, coding and narrative writing.
Drug Safety Associate
Back Bay Clinical Research Unit, Boston, MA 2015 to 2016
Entry role processing serious adverse event reports for two academic sponsored studies.
- Entered and coded serious adverse event reports within the study reporting window.
- Chased site queries on missing outcome and causality information.
- Filed source documents and kept the study safety binder audit ready.
Licensure and Certification
Regulatory Affairs Certification, Regulatory Affairs Professionals Society, 2020
Member, Drug Information Association
Education
Master of Science in pharmacology, Boston University, 2015
Bachelor of Science in biology, University of Massachusetts Amherst, 2013
Core Skills
Case processing management · Expedited reporting · Argus Safety · Periodic safety update reports · Signal detection support · Inspection readiness · TrackWise · Corrective and preventive action · Team leadership · Standard operating procedure authoring