プロフィール詳細

プロジェクトを作成

★★★★★

☆☆☆☆☆

★★★★★

☆☆☆☆☆

Dr. David M.に依頼

Hungary

Senior Medical Writer | QPPV | Medical Device Regulatory Expert | Pharmacovigilance Consultant |

プロフィール概要

✔ Pharmacovigilance Physician, Medical Regulatory Writer, LQPPV, Project Manager, Clinical Trials Regulatory Expert. ✔13+ years professional medical experience. ✔Expert in ICH, GVP and GCP, Medical Devices Regulation (MDR) 2017/745. ✔Full cover Drug and Device Safety for Pre/Post-Marketing on central, global, regional, and local safety office scales. ✔Writing &/or Reviewing Drug & Device Documents for FDA and EMA: eCTD, ACO, CO, RMP, PSUR, DSUR, SMP, SDEA, CEP, CER, PMSP, PMSR, PMCF, SSCP, IFU, CCDS, CTDs, SmPCs, PILs, ICSR, SAE, SUSAR, Protocols, ICFs, CSRs, IBs, IND, NDA, MAA. ✔On-site audit readiness support or remote auditing for PV systems and processes implementation, PV compliance, PV agreements, writing SOPs and PV trainings. ✔ Project activity management, initiation, administration, communications and coordination, meetings scheduling and documentation (meeting minutes), resource planning, time management, tracking performance, monitoring, deviation memos, CAPA, trial unblinding and ensuring client satisfaction. ✔Case registration, tracking, Central and regional safety mailbox management, gateway management Sharepoint and archiving, triage, data entry, narrative, manual MedDRA/WHO-DD coding, labeling and causality, medical review, quality check and distribution through an E2B gateway, EVDAS cases download, reconciliation and maintenance in Argus and ArisG databases of tens of thousands of cases world wide. ✔Literatures search and assessment of tens of thousands of articles (Embase, Pubmed, Cochrane library, MAUDE, Biosis Previews) for Evidence based Safety, Efficacy and Effectiveness information, and performing individual and cumulative benefit/risk evaluations, including any emerging safety signals, concerns and risk/benefit profile. ✔Responsible for overall signal detection, monitoring, evaluation, interpretation of safety information and appropriate management. ✔Responsible for the integration, analysis, and interpretation of complex safety information from all and any available source (non-clinical, preclinical, literature, safety databases, exposure, etc.) ✔Assessing potential impact on benefit and risk as well as related consequences.

専門分野

• ★ Pharmacovigilance/Drug Safety Monitoring
• ★ Regulatory Writing
• ★ Medical Writing
• ☆ Medical Devices
• ☆ Clinical Trials
• ☆ Technical & Scientific Writing

サービス

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Clinical Trial Documentation, Technical Writing, Copywriting, Newswriting

Research User Research, Meta-Research, Feasibility Study, Fact Checking, Gap Analysis, Gray Literature Search, Systematic Literature Review, Secondary Data Collection

Consulting Scientific and Technical Consulting

Data & AI Predictive Modeling, Statistical Analysis, Algorithm Design-Non ML, Data Visualization, Data Processing, Data Insights

Product Development Prototyping

職務経験

Consultant

CEE Services

11月 2020 - 現在

学歴

Medical Degree (MD)

Semmelweiss University

9月 2003 - 8月 2009

認定資格

• Qualified Person for Pharmacovigilance

  Pharmaceutical

  1月 2021 - 現在