Antoinette Poindexter

Operations Scientist @Johnson & Johnson Innovative Medicine

Philadelphia, PA, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Aug 2021 — Present

Operations Scientist @Johnson & Johnson Innovative Medicine

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Horsham, PA, US

Conduct case processing of adverse event reports in alignment with global regulatory requirements, corporate policies, SOPs, & pharmacovigilance guidelines to ensure compliance. Perform end to end case management, including triage, narrative creation, manual coding, data entry, label selection, and approval within safety databases- Execute quality review of Individual Case Safety Reports (ICSRs), ensuring accuracy, completeness, and appropriate documentation of source materials. Collaborate with Global Case Receipt and Global Medical Safety Operations Physicians to clarify case information and ensure case integrity- Manage additional pharmacovigilance case processing tasks such as serious adverse event (SAE) reconciliation, unblinding, protocol updates, deviation memos, and case deletions. Provide oversight of vendors for assigned products, ensuring compliance with quality and performance standards- Serve as product portfolio subject matter expert, acting as key contact for internal teams and external partners- Lead operational management activities including workload balancing, productivity monitoring, vendor oversight meetings, and quality review of ICSRs- Support team leadership efforts by liaising with senior staff for workload management, leading meetings, and resolving case processing issues- Supervise product specific daily workloads to maintain timely submissions and compliance with global regulatory timelines- Monitor ICSR data consistency reports and aggregate reporting calendars to identify and resolve processing inconsistencies and ensure deadlines are met-Maintain expertise in internal procedures, and global PV agreements; contribute to revisions and training efforts to ensure compliance- Participate in global and local projects focused on audit and inspection readiness, process improvement, and corrective/preventative action planning- Act as designated process and product expert, providing guidance across cross functional teams.

EDUCATION

N/A

Temple University

Bachelor of Science (BS)

N/A

Temple University

Bachelor of Science - BS

N/A

Philadelphia HS for Girls

High School Diploma

SKILLS

CROOncologyClinical Data ManagementClinical ResearchMentoringPharmaceutical IndustrySopDrug SafetyClinical DevelopmentClinical TrialsProblem SolvingDocumentationPharmacovigilanceSoftware DocumentationCtmsValidationQuality AssuranceRegulatory AffairsPharmaceuticalsRegulatory SubmissionsHealthcare

ABOUT ANTOINETTE POINDEXTER

With over 20 years in pharmacovigilance, I brought deep expertise in adverse event case…

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Antoinette Poindexter — Operations Scientist at Johnson & Johnson Innovative Medicine in Philadelphia, PA, US | Unifers