Aspiring Virtual Assistant. Corporate Administrative experience. Willing to be trained. Proficient in
skills (Microsoft Word, Microsoft PowerPoint, Microsoft Outlook, Microsoft Excel.
Filing and research. Thesis Consultation and APA style writing correction for BS Pharmacy students/Medical Allied courses.
Report generation. Health,Pharmaceuticals and FDA
QUALIFICATION HIGHLIGHTS • Knowledgeable in clinical research including administrative skills,clinical research budgeting, ICH- GCP standards, IRB protocol submissions, on-going regulatory and IRB/Ethics Committee phases, and drug safety reporting. (Trainings from Astra Zeneca Phils)• Demonstrated competencies in managing research data, verifying source documents and data collection charts, and severe adverse events reporting. • Good ability to translate medical terms and drug products.• Knowledgeable in ACTD product dossiers assessment/evaluation. (Drugs & Medical Device)• QPIRA Certificate Holder (Qualified Person in Industry) Medical Device,Drugs,Pharmacovigilance• Provides high quality reliable information in a timely fashion to direct and support business objectives and ensure compliance with health authority (FDA and PDEA ), hence performs the role of the "qualified person" in all regulatory affairs issues.• Ensures all pharmaceutical materials (like packaging materials and promotional materials) comply with regulation of local health authorities with close coordination with overseas HQ and local area regulatory.•Knowledgeable in Adobe Acrobat & Microsoft Applications
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