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