Clinical Affairs / Pharmacovigilance / Medical Writing
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- auf Anfrage
- 22417 Hamburg
- auf Anfrage
- de | en
- 13.03.2024
Kurzvorstellung
Qualifikationen
Projekt‐ & Berufserfahrung
1/2018 – 10/2022
Tätigkeitsbeschreibung
Clinical strategies for medical devices for ventilation therapy and anesthesia
Clinical Evaluations and Post Market Clinical Follow-Ups according to MDR Literature Search according to Evidence-Based Medicine
Process Owner for global SOPs for Clinical Evaluation Report / PMCF Implementation of regulatory requirements according to MDR and MDCG guidelines Audits according to ISO13485, ISO14155 and MDR (Clinical Audit)
Anästhesiologie
8/2011 – 12/2017
Tätigkeitsbeschreibung
Scientific and Clinical Affairs
QPPV, Stufenplanbeauftragte according to AMG §63a for wound and hands disinfectants
Setup of the pharmacovigilance system, PSMV
Signal management (GVP Module IX)
PSURs (EU-Directive 2001/83/EC and GVP Module VII) Risk Management Plans (GVP Module V)
Adverse reactions reporting (GVP Module VI) Literature monitoring
Inspections (incl. FDA) and Audits
Good clinical practice (GCP), Pharmaforschung
9/2007 – 7/2011
TätigkeitsbeschreibungPSURs, DSURs, Adverse reactions reporting, Clinical Expert Statements, Literature Search; for different drugs incl. analgesics and oncological therapeutics
Eingesetzte QualifikationenDienstleistung (allg.), F&E Management
Ausbildung
Hamburg
Über mich
Subject Matter Expert for medical device Clinical Evaluation Reports (CERs) and Plans (CEPs), Summary of Safety and Clinical Performance (SSCP), Post-Market Surveillance (PMS) Plans/Reports, and Post-Market Clinical Follow-up (PMCF) Plans for regulatory compliance (EU MDD and EU MDR).
Subject Matter Expert for pharmacovigilance QPPV, Pharmacovigilance System Master File (PSMF), Periodic Safety Update Report (PSUR), Development Safety Update Report (DSUR), Signal Detection, ICSR, SUSARs for regulatory compliance (ICH and GVP).
If you need help sorting out the clinical affairs or post-market surveillance/vigilance parts of your business, I'd love to help!
Weitere Kenntnisse
EMBASE, Pubmed / MEDLINE
Distiller SR
Aras
Pro-X
MS-Office, Excel, Powerpoint
Persönliche Daten
- Deutsch (Muttersprache)
- Englisch (Fließend)
- Europäische Union
- Schweiz
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