freiberufler GXP Consultant / Trainer auf

GXP Consultant / Trainer

  • auf Anfrage
  • 50968 Köln
  • National
  • de  |  en
  • 01.04.2021


Mein Name ist Dr. M. B. und ich bin Experte im Bereich der Pharmakovigilanz.
Fragen/Projekte zur Pharmakovigilanz, Klinische Prüfungen und Training (GVP/GCP/GMP) - Dann kontaktieren Sie mich!

Ich biete

  • Aus- / Weiterbildung
  • Forschung & Entwicklung (allg.)
  • Good clinical practice (GCP)
  • Gute Herstellungspraxis (GMP)
  • Klinische Monitor (CRA)
  • Klinische Studie
  • Medizinforschung
  • Pharmaforschung
  • Pharmakovigilanz
  • Pharmazie
  • Qualitätsmanagement (allg.)
  • Regulatory Affairs

Projekt‐ & Berufserfahrung

Trainer - GMP Manager
LVQ Lehr- und Versuchsgesellschaft für Qualität mb, Mülheim an der Ruhr
2/2019 – 1/2021 (2 Jahre)

2/2019 – 1/2021


Good Clinical Practice (GCP) - (Clinical Trials; Investigator, CRA; Sponsor/CRO; IMPD; Product Specification File; Labelling; Certification of Analysis and Conformity)
Customers Complaints (PQC, Product Returns; Pharmacovigilance; Trendanalysis; Crisis Management; Customer Satisfaction; Reprocessing/Reworking; Continual Improvement: Monitoring and Measurement of Processes / Product; ReCall)
Quality Risk Management (FMECA; FTA; Change Control; PQC; PQR)
Vendor Management / Warehouse and Transport requirements (Outsourcing; Traceability, Quality/Service Agreements, Supply Chain, Supplier Qualification, Selection of Supplier / Criteria and Classification)
Hygiene Standards in GMP Area (chemical and microbiological Contamination; microbiolgical monitoring and methods; Swab; SD plate; cleaning requirements; cleanroom technology and requirements)

Eingesetzte Qualifikationen

Aus- / Weiterbildung, Good clinical practice (GCP), Gute Herstellungspraxis (GMP), Qualitätsmanagement (allg.)

Patient Safety Physician
AstraZeneca, Wedel
1/2017 – 11/2017 (11 Monate)

1/2017 – 11/2017


• Description / Renewal local pharmacovigilance system related to Quality
Management aspects
• Providing oversight for the “Stufenplanbeauftragter” particularly about the
Processes in Pharmacovigilance department – Implementation Interface QPPV
/ Handling Pharmacovigilance System Master File (PSMF).
• Review / Adaption / Writing SOPs and Integration of local Pharmacovigilance
• “Dear Doctor Letter”; Urgent Safety Restriction; Variation (Interface Regulatory
Affairs – Renewal / Referral)
• Safety-related Health Authorities Request
• Safety in Clinical Trials, Managing Aggregate Safety Reports and IB / CCDS /
• Safety Case Processing; Signal detection activities; Literature Monitoring
• Drug Safety Agreements for Licensee Partner, Service Provider, Vendors
• Establishment Interface to Quality Assurance and Pharmacovigilance for Identification & Analysis of PQCs.
• Implementation / development of risk management/Crisis management processes (Stufenplan)
• Implementation / development Risk Mineralization Measures, ReCall Procedure
& Supply Shortage
• Preparation and Implementation Mock-ReCall
• Preparation Pharmacovigilance Audit / Cooperation Audit plan und preliminary
audit questions
• Managing Training (Mock Interviews) for Staff in local Pharmacovigilance
processes, SOPs, GVP Audit
• Identifying and implementing PV regulatory requirements (guidelines,
regulations, directives)

Eingesetzte Qualifikationen

Medizinforschung, Pharmaforschung, GxP, Qualitätsmanagement (allg.)

Trainer - Pharmacovigilance
Mibeg Institut für Medizin, Köln
5/2016 – 3/2021 (4 Jahre, 11 Monate)
Life Sciences

5/2016 – 3/2021


• Pharmacovigilance System - Quality cycle; -goals; FMECA; Pharmacovigilance
Processes, Key Performance Indicators and Key Risk Indicator, PSMF,
Compliance Report, SOP, Job description, Tasks, Responsibilities) – Interfaces
with other departments
• GVP Pharmacovigilance Inspection / Audits (Preparation / Implementation /
Conclusion) – Objectives, Planning, Preparation, Performance, Compliance
Reporting – CAPA Management, Gap Analysis, Pre-/Re-Audit)
• Role / Tasks / Interface “Stufenplanbeauftrager”, “Informationsbeauftragter” &
• Clinical Safety (ICH E1 – E2F/E3) - Clinical Safety Data Management,
Pharmacovigilance Planning
• Role and Tasks Medical / Clinical Monitor /Investigator & Pharmacovigilance
Trainer in Clinical Trials (SAE-Workflow, Safety Management Plan,
Reconcilation Plan, Safety Data Review and Assessment)
• Clinical Study Protocol; Investigator Brochure; Informed Consent; Patient
Information, Clinical Study Report
• Phase I Clinical trials (Objects, MABEL/NOAEL/MTD, High Risk FIM, Recruiting,
Safety Stopping Rules, Non-Clinical Data, Study Sites, special population –
Pharmacokinetic, extrinsic/intrinsic factors)
• Clinical Development Plan (Goals; Target Indication, Medical / Regulatory
Strategy; Description product)
• Development Risk Management Plan (Clinical pharmacology; Evaluating and
mitigation Risk, Action)
• Investigator Site Audit (Goals, Preparation, Implementation)
• Safety Case Processing, Narrativ, MedDRA / WHO-DD-Coding, Reporting
Obligations, Unblinding for Safety Reason (Sponsor, Study Site, DSMB)
• Signal management (detection, evaluation and assessment), Medical safety
evaluation, Benefit-Risk Assessment
• Risk Management / “Stufenplan” / RAS / Health Authorities Request
• Managing Risk Management Plan; risk mineralization activities & Measures -
Safety Communication (Dear Doctor Letter)
• Managing / Preparation Aggregate Safety Reports (DSUR, PSUR, RSI)
• Task / Responsiblities “Informationsbeauftragter”: Labelling / Guidelines
Packaging material, Package Size; Package Leaflet, Summary of Product
Characteristics - QR-Code / QRD-Template
• Regulatory Affairs (CP; DCP; MRP; NP); Content Approval Dossier; Renewal,
Referral, Variation
• PASS / PAES (Type of studies, relevant approval, study protocol, Data collection,
Case reporting, Final progress / study report; Interface Risk-management plan
& action; Role QPPV, Role Approval Procedure)
• Non-Interventionell Studies (Structure, goals, Study design Observation plan,
Statistic Analysis Plan)

Eingesetzte Qualifikationen

Aus- / Weiterbildung, Good clinical practice (GCP), GxP, Klinische Monitor (CRA), Klinische Studie, Qualitätsmanagement (allg.), Regulatory Affairs Management

Drug Safety Manager
anwerina deutschland GmbH, Mannheim
5/2016 – 7/2016 (3 Monate)

5/2016 – 7/2016


• Preliminary / Support / Conclusion Local Health Authority Inspection
• Review / Update Quality management system accordingly GxP (GDP/GVP) – QM
Manual, Logbook
• Maintain Key Performance Indicators (KPI) for relevant functions
• Review / Update local SOPs & Process / CAPA Management / Gap Analysis
• Preparation Self-Inspections; Mock-Interviews for Staff, Training Staff for
• Development local GVP relevant Processes and Interfaces
“Stufenplanbeauftragter” vs. QPPV
• Implementation Recall and Safety Communication Procedure – Interface
Quality department
• Development / Implementation processes for “Informationsbeauftragter” -
(AMG / HWG – Release advertising material / Approval Labelling requirements
Package Leaflet / SmPC / Package; Release Information and Education material)

Eingesetzte Qualifikationen

GxP, Qualitätsmanagement (allg.)

Trainer - Klinsche Forschung
Pharmaakademie, Deutschlandweit
8/2015 – offen (5 Jahre, 9 Monate)

8/2015 – offen


• ICH-GCP Guidelines / Requirements & Regulation in Clinical Trials
• Roles / Responsibilities / Tasks - Sponsor, CRO, Investigator, Clinical Research
Associate (CRA), Ethics, Health Authority (purpose, process, objectives, content)
• Clinical development – Phases, Study Designs / Implementation / Objectives /
Role Drug Approval
• Phase II Clinical trials (Dose-Finding Studies; Proof of Concept Studies; Objects)
• Essential documents (Investigator Brochure; Informed Consent; Study
Protocol, Case Report Form; Agreements, Investigator Site File, Trial Master
File, etc.)
• Documentation in clinical trials (eCRF; ISF; Health Record; SAE-Report Form)
• Safety handling Clinical Trials (SAE Reporting/Workflow, Review Aggregate
Data, CVR-/DILI- Management)
• Handling Study medication (Storage, Unblinding process, drug accountability;
Interface GMP and GCP)
• Risk-Based-Monitoring – Quality Control & Quality Assurance
• Quality management in Clinical Trials – Audits / Inspections and Monitoring
• Preparation / Implementation Audits and Inspections in Clinical Trials (CRO-
and Investigator- Site Audit)

Eingesetzte Qualifikationen

Aus- / Weiterbildung, Klinische Monitor (CRA), Klinische Studie, Good clinical practice (GCP)

Drug Safety Manager
Novartis Pharma GmbH; UCB Pharma GmbH, Janssen-Cil, Nürnberg, Neuss, Langenfeld
3/2013 – 7/2015 (2 Jahre, 5 Monate)

3/2013 – 7/2015


• Case Processing, Signal detection and Local Literature Monitoring
• Managing Aggregate Safety Reports (PSUR, DSUR) - Overview, Coordination /
Review, Submission
• Identification, Analysis, Assessments and reporting of SUSARs from Clinical
• Ensure SAE reconciliation and compliance monitoring activities (Clinical Trials /
• Answering inquiries from doctors, pharmacists and patients (Interaction with
Medical Information)
• Drug Safety specific project monitoring Non-Interventional Studies (NIS -
Observation studies; Registry) – project planning (Resource- and Time
management, Vendor management, milestones, Agreements)
• Review/Approval Summary of Product Characteristics (SmPC) and Package
Leaflet (PL)
• Cooperation/Preparation risk mineralization activities, Local Risk Management
Plan & Education material
• Cooperation with Regulatory Affairs in case of Variation, Referral and Renewal
• Drug Safety Agreements for Vendors, License partners and service provider
• Interface management with other departments locally and at global level.

Eingesetzte Qualifikationen

Klinische Studie, Pharmaforschung, GxP

Medical Case Evaluator (Festanstellung)
Bayer Pharma AG, Wuppertal
9/2008 – 9/2012 (4 Jahre, 1 Monat)

9/2008 – 9/2012


• Responsible for the medical evaluation and assessment of complex ICSRs from clinical development projects as well as spontaneous case reports.
• Reporting sources including medical literature as well as from clinical trials and post-marketing surveillance studies to ensure high medical quality and compliance with all health authority requirements.
• Ensure medical plausibility, consistency and completeness of ADR case reports.
• Medical coding (MedDRA) of various case data including all AE and Drug terms (WHO-DD)
• Manage the review of reports on adverse events incl. writing medical causality comments.
• Confirm determination of seriousness, assess drug product causal association and assign labeling status.
• Analyze difficult medical context by using scientific public and internal sources and prepare medical expert’s reports.
• Identify critical case reports that require immediate attention and pre-select cases that are potentially suitable for extended discussion in Aggregate Safety Reports.
• Collaborate effectively with the study team (Clinical Operation) and external partners (CRO) to supervise/coordinate the SAE/AEs processing and evaluation of signal cases of an international clinical trial (Phase 3) to ensure all safety requirements. This provides guidance on SAE-handling to ensure compliance and medical follow- for staff and CRO members to validate events und potential risks.
• Maintaining high quality standards in the careful and timely analysis of reports of serious adverse drug reactions, including support in the continuous improvement of systems and processes. Implementation of corrective and preventive action (CAPA) as applicable

Eingesetzte Qualifikationen

Klinische Studie, Pharmaforschung, GxP, Qualitätsmanagement (allg.)


Methoden der Visualisierung
Oktober 2019
GVP-Compliance (Key Performance Indicator, Compliance Reports; PV-Audits; PV-Agreements)
April 2019
Oktober 2017
Methoden für interaktive Seminare
September 2017
Stufenplanbeauftragter vs. QPPV
Juni 2017
Periodische Berichte - PSUR / DSUR / Risikomanagement Plan
Januar 2016
Fach-/Führungskräfte Training / Kommunikations-/Konfliktmanagement
Februar 2015
Regulatory Affairs-Know-how (Renewal; Referral; Variation)
Dezember 2014


Jahr: 2008
Ort: Köln
Biologie - Schwerpunkt: Biochemie, Pharmakologie
(Promotion im Fach Biochemie)
Jahr: 2006
Ort: Köln
Clinical Research Associate (CRA) / Klinische Forschung
Jahr: 2006
Ort: Köln


Professional pharmacovigilance working experience (10 years)
• Pre- / Post-marketing Pharmacovigilance in the Pharmaceutical Industry
• Working Experience in Pharmacovigilance Projects – incl. review/implementation Drug
Safety processes, Vendor Management and managing of aggregate safety reports.
• Working Experience as a Trainer in (1) Pharmacovigilance, (2) Clinical Trials and (3) GMP
• Leading / Coaching intercultural team of 10 Trainee – advise in GCP / GVP / GMP
• Working Experience in pharmacovigilance audits and inspection

Persönliche Daten

  • Deutsch (Muttersprache)
  • Englisch (Fließend)
  • Europäische Union
12 Jahre und 7 Monate (seit 09/2008)
2 Jahre


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