Sr. Drug Safety Consultant Resume

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

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