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Sr. Drug Safety Consultant Resume

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SUMMARY

  • Registered Nurse with healthcare, clinical research, pharmacovigilance, materiovigilance and cosmetovigilance knowledge. Experience managing clinical trial studies and post - marketing cases within clinical research and pharmaceutical organizations. Committed to high-quality work to ensure safety and drug surveillance for the public. Well versed in ICH GCP guidelines, SOPs and regulations.

TECHNICAL SKILLS

  • Argus database (MedDRA/WHO Drug dictionary, Oracle AERS
  • Medidata/Rave database, TMF, IVEA, InForm/EDC, VCAS database
  • Datalabs, Bioclinica and PMED. Microsoft word, PowerPoint, Excel
  • Outlook, xClinical (Marvin) and Lotus Notes.

PROFESSIONAL EXPERIENCE

Confidential

Sr. Drug Safety Consultant

Responsibilities:

  • Therapeutic areas: biomedical devices, cellular therapies, oncology (diffuse large B-cell lymphoma) & CAR-T technology
  • Developing US pharmacovigilance department through business process optimization for safety team
  • Conducting procurement activities including RFPs, RFIs and RFQs for NDA process and long-term follow up study process
  • Collaborating with regulatory team, investigators, site staff, CROs and site monitors to optimize study engagement
  • Authored & contributed to protocols, investigator brochures, safety procedures, case processing & data entry guidelines
  • Educated US team on roles & responsibilities, workflow, international & US regulatory requirements and timelines

Confidential

Pharmacovigilance & Vendor Oversight Associate

Responsibilities:

  • Therapeutic areas: Immunology, hereditary angioedema, ophthalmic, hematology, genetic disease, neuroscience & oncology
  • Oversaw workflow activities and created training documents for safety vendors to ensure quality and compliance
  • Completed quality review for concise narratives, correct coding terms; causality per IB or PI and serious criteria
  • Performed literature review of medical articles, scientific documents, clinical trial documents for interpretation and validity
  • Oversaw reporting deadlines, submissions and educated vendors on international and US regulatory requirements
  • Managed CAPAs, late submissions and performed root cause analysis to review error trends and achieve highest quality
  • Collaborated with safety team to prepare for planned and unplanned regulatory inspections, vendor audits and internal audits
  • Managed reconciliation, deactivations, case duplication errors, validation corrections and device/product quality complaints

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