GXP Consultant / Trainer

1/2021 – 11/2023

• Post-Marketing Pharmacovigilancce
• ICSR Management and Literature Monitoring
• Medical Evaluation ICSR
• SAE Reconciliation
• Local Signaldetection / ICSR Evaluation
• PTC Handling and Assessment
• Handling Risk Management Plan and Education Material

Gute Klinische Praxis, GXP, Pharmakologie, Qualitätsmanagement (allg.)

9/2020 – 7/2023

• Preparation audit for Pharmacovigilance Vendor
• Preparation / Implementation Supplier qualification
• Preparation / Implementation Internal Audits
• Review / Update Quality Management System accordingly GxP / ISO:9001
• Review / Update SOPs & Process
• Management Review & Quality Risk Management
• CAPA and Deviation Management

Auditor, GXP, Projektdurchführung, Qualitätsmanagement (allg.)

1/2019 – 12/2022

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)

Aus- / Weiterbildung, Gute Klinische Praxis, Good Manufacturing Practices, Qualitätsmanagement (allg.)

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
Processes
• “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 /
SmPC / PL
• 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)

Gute Klinische Praxis, GXP, Medizinforschung, Drug Discovery, Projektdurchführung, Qualitätsmanagement (allg.)

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
Inspection
• 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)

Auditor, GXP, Qualitätsmanagement (allg.)

5/2016 – offen

• 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” &
QPPV (AMG, AMWHV, GVP)
• 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)

Aus- / Weiterbildung, Gute Klinische Praxis, GXP, Klinische Arbeiten, Klinische Forschung, Qualitätsmanagement (allg.), Regulatory Affairs

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)

Aus- / Weiterbildung, Gute Klinische Praxis, Klinische Arbeiten, Klinische Forschung, Projektmanagement

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
Trials.
• Ensure SAE reconciliation and compliance monitoring activities (Clinical Trials /
NIS / PASS)
• 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.

GXP, Klinische Forschung, Drug Discovery, Pharmakologie

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

Klinische Forschung, Drug Discovery, GXP, Qualitätsmanagement (allg.)