Karin Maria Thelen
Torgau
Summary
Seasoned pharmacovigilance professional with over 20 years of experience across academic research, R&D pharmaceutical organizations, global CROs, and health authorities. Demonstrates a robust scientific and analytical foundation, excelling in operational safety and pharmacovigilance lifecycle management. Proven track record as Qualified Person for Pharmacovigilance at both local (DACH) and EU levels for small to medium-sized pharmaceutical companies. A collaborative team player adept at engaging with key stakeholders including health care professionals, licensing partners, and regulatory bodies.
Overview
18
18
years of professional experience
Work History
Head of Drug Safety
Cardior Pharmaceuticals GmbH
Hannover
06.2022 - Current
- Established and ensured an effective pharmacovigilance system for Cardior.
- Collaborated on development, implementation and evaluation of safety protocols for studies.
- Conducted ongoing evaluations of benefit-risk profiles for development products.
- Authored and evaluated safety-related segments of Investigator Brochure, Study Protocols, and Development Safety Update Reports.
- Served as primary contact for investigators and CRO staff regarding safety-related topics.
Associate Director Pharmacovigilance
PharmaLex GmbH
Friedrichsdorf
04.2021 - 05.2022
- Led initiatives as outlined in the role of a Senior Manager Pharmacovigilance.
- Developed and sustained strong connections with customers, acting as main liaison.
- Optimized customer business workflows by analyzing and improving processes.
- Designed tailored solutions to meet client-specific needs.
- Managed inventory and resources to ensure availability and cost-effectiveness.
Senior Manager Pharmacovigilance
PharmaLex GmbH
Friedrichsdorf
12.2019 - 03.2021
- Established and maintained Pharmacovigilance Systems.
- Executed duties as both QPPV and local PV responsible person across the DACH region.
- Generated development safety update reports, risk management plans, and signal detection reports.
- Evaluated adverse events from clinical trials, spontaneous reporting systems, and literature.
- Developed precise documentation on drug-related safety concerns tailored to specific queries.
- Prepared and maintained Pharmacovigilance System Master Files (PSMFs).
- Drafted and executed Pharmacovigilance Agreements (PVAs).
- Developed comprehensive QA materials tailored to both PharmaLex projects and external client needs.
- Conducted pharmacovigilance training sessions.
- Supported audits and regulatory inspections.
Head of Quality Assurance
LAW Services GmbH
Leipzig
10.2018 - 03.2019
- Configured and maintained Good Manufacturing Practice (GMP) Quality Assurance (QA) system.
- Led the QA department, supervising and coordinating activities of a team of four.
- Facilitated GMP-QA processes including training, SOP system management, and oversight of change control procedures.
- Streamlined CAPA, deviation handling, and qualification-validation activities to uphold compliance standards.
- Coordinated audits and inspection readiness to ensure regulatory alignment in operational practices.
Senior Safety Surveillance Manager Respiratory and Oncology
Mundipharma Research GmbH & Co KG
Limburg
05.2007 - 03.2018
- Contributed drug safety expertise for clinical development, marketing approval submissions, and regulatory processes.
- Conducted detailed safety evaluations across assigned therapeutic areas emphasizing product vigilance.
- Assisted in the creation and update of product labels like IBs, SmPCs, PILs.
- Addressed customer inquiries (HCPs, patients, regulatory authorities, and other interfaces such as regulatory affairs and medical information) regarding safety issues.
- Oversaw Respiratory sub-team operations within Safety Surveillance & Risk Management.
- Negotiated and structured PV contracts for assigned products.
- Drafted and reviewed standard operating procedures to maintain compliance.
- Supported due diligence efforts through extensive pharmacovigilance knowledge, and strategic input.
Pharmacist
Damian Apotheke/Marien Apotheke
Bonn And Aachen
12.2006 - 04.2007
- Served as Deputy Pharmacy Head
Trainee
Federal Institute for Drugs and Medical Devices (BfArM)
Bonn
09.2006 - 10.2006
- Examined the association between drugs, drug classes, and adverse reactions in German youth over a decade (1995 - 2005) via data from the PV department at BfArM.
Education
Expert Pharmacist for Drug Information - Vocational In-service Training
Rheinische Friedrich-Wilhelms-Universität of Bonn
Bonn, Germany12-2006
Ph.D. - Pharmaceutical & Medicinal Chemistry
University Hospital of Bonn, Clinical Pharmacology
Bonn, Germany02-2006
License as Pharmacist - Pharmacy
Rheinische Friedrich-Wilhelms-Universität of Bonn
Bonn, Germany08-2002
License as Pharmaceutical-Technical-Assistant - Pharmacy
Pharmazeutisch-Technische Lehranstalt Des Kreises Aachen
Baesweiler, Germany03-1997
Skills
- Strong Teamwork Skills
- Facilitate Clear Communication
- Strong Sense of Accountability
- Constructive Resolution Mindset
- Experienced in Project Management
- Effective Task Prioritization
- Analytical and Critical Thinking
- Responsive to Change
Affiliations
- German Society for Pharmacy (DPhG e.V.)
- Drug Information Association, DIA
Awards
- Young Investigator Award, August 2005, Kern Aspen Lipid Conference
- Hans J. Dengler Award, October 2006, 8th Annual Congress on Clinical Pharmacology
Personal Information
Title: PhD, Pharmacist
Summary - Key Competencies
- Pharmacist with > 15 years of experience in the pharmaceutical industry
- Comprehensive and very well-founded expertise in the areas of pharmacovigilance, clinical development, drug approval and quality management
- Highly motivated employee who tackles difficult tasks with great enthusiasm
- Strong project management and proven leadership skills
- Experience in personnel management
Languages
German
First Language
English
Advanced (C1)
C1
French
Elementary (A2)
A2
Italian
Elementary (A2)
A2
Spanish
Beginner
A1
Dutch
Beginner
A1
Timeline
Head of Drug Safety
Cardior Pharmaceuticals GmbH
06.2022 - Current
Associate Director Pharmacovigilance
PharmaLex GmbH
04.2021 - 05.2022
Senior Manager Pharmacovigilance
PharmaLex GmbH
12.2019 - 03.2021
Head of Quality Assurance
LAW Services GmbH
10.2018 - 03.2019
Senior Safety Surveillance Manager Respiratory and Oncology
Mundipharma Research GmbH & Co KG
05.2007 - 03.2018
Pharmacist
Damian Apotheke/Marien Apotheke
12.2006 - 04.2007
Trainee
Federal Institute for Drugs and Medical Devices (BfArM)
09.2006 - 10.2006
Expert Pharmacist for Drug Information - Vocational In-service Training
Rheinische Friedrich-Wilhelms-Universität of Bonn
Ph.D. - Pharmaceutical & Medicinal Chemistry
University Hospital of Bonn, Clinical Pharmacology
License as Pharmacist - Pharmacy
Rheinische Friedrich-Wilhelms-Universität of Bonn
License as Pharmaceutical-Technical-Assistant - Pharmacy
Pharmazeutisch-Technische Lehranstalt Des Kreises Aachen
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