Jessica Dyck-Pharmacovigilance Quality Expert / Graduated Plan Officer (GPO)

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Experience
Deputy Graduated Plan Officer (dGPO)
ProPharma Group
- Acting as the German Deputy Graduated Plan Officer in accordance with AMG and AMWHV, including 24/7 availability for German competent authorities
- Ensuring ongoing compliance of the local PV system and oversight of the safety of medicinal products marketed in Germany
- Collection, evaluation, documentation, and reporting of safety information (ADRs, quality complaints, signals)
- Coordination of regulatory reporting, authority notifications, recalls, and distribution restrictions
- Close collaboration with QPPV, QP, EU/EEA stakeholders, and PV partners
- Support of inspection readiness, local literature review, training compliance, and maintenance of PV documentation
Independent Pharmacovigilance Consultant
Freelance Pharmacovigilance Service Provider
- Independent pharmacovigilance consultant providing PV quality and compliance services to pharmaceutical companies and PV service providers
- Strong focus on PV audits in accordance with EU GVP Module IV, including audit planning, execution, reporting, and CAPA management
- Development and optimization of PV quality systems, processes, and SOPs
- Support of inspection readiness and regulatory compliance activities
- Strategic support in PV contract negotiations and partner management
Pharmacovigilance Manager
medac GmbH
- Built and implemented a global risk-based audit system in line with EU GVP
- Conducted risk assessments for PV partners and internal critical processes
- Supported and co-conducted self-inspections, and conducted over 100 PV audits for partners and affiliates (onsite/remote)
- Managed PV audit lifecycle: planning, execution, reporting, CAPA follow-up
- Negotiated, drafted, and maintained PV agreements and post-marketing study-related contracts globally
- Managed global PV partners and affiliates, including reconciliation process implementation
- Developed and maintained SOPs and PV documentation including PSMF and PSSF
- Managed ICSR and signal management, including review of local literature
- Collaborated on validation of PV Partner Database
- Coordinated and supported authority inspections
- Delivered internal and external PV trainings
- Facilitated cross-functional projects and interface management (QA, Regulatory, Service providers)
Pharmacist and Quality Representative (QB)
Apotheke am Kreiskrankenhaus
- Led activities related to medication safety (medication therapy safety, AMTS)
- Maintained the quality management system
Deputy Pharmacy Manager & Quality Representative (QB)
Ahorn Apotheke
- Acted as deputy head of the pharmacy
- Responsible for maintaining and improving the quality management system in line with German pharmacy regulations (ApBetrO)
- Prepared and actively participated in regulatory inspections
Internship in a hospital pharmacy
Exchange Semester
- Gained international insights of healthcare environment through internship in a hospital pharmacy
Industry experience
See where this freelancer has spent most of their professional time.
Experienced in Pharmaceutical and Healthcare.
Business area experience
See which departments and functions this freelancer has contributed to most.
Experienced in Quality Assurance, Audit, Strategy, Research and Development, and Operations.
Skills
Eu Gvp-Compliant Pv Audits (Module Iv, Risk-Based Approaches)
Capa, Deviation & Reconciliation Management
Development And Maintenance Of Pv Quality Systems, Sops, Psmfs/Pssfs
Pv Agreement Negotiation And Global Partner Oversight
Inspection Readiness And Authority Interaction Support
Pv Training And Compliance Consulting
Structured, Analytical, And Pragmatic Working Style
Rational And Solution-Focused Thinking
Strong Intercultural Communication And Collaboration Capabilities
Languages
Education
Ahorn Apotheke
Practical Year (PJ) · Cologne, Germany
Technische Universität Braunschweig
Pharmacy Studies · Braunschweig, Germany
Statistics
Experience
Global experience
Expertise
Profile
Frequently asked questions
Have questions? Find more information here.
Jessica is based in Pinneberg, Germany.
Jessica speaks the following languages: German (Native), English (Advanced), Spanish (Elementary), French (Elementary).
Jessica has at least 13 years of experience. During this time, Jessica has worked in at least 6 different roles and for 6 different companies. The average length of individual experience is 2 years and 1 month. Note that Jessica may not have shared all experience and actually has more experience.
Based on recent experience, Jessica would be well-suited for roles such as: Deputy Graduated Plan Officer (dGPO), Independent Pharmacovigilance Consultant, Pharmacovigilance Manager.
Jessica's most recent position is Deputy Graduated Plan Officer (dGPO) at ProPharma Group.
In recent years, Jessica has worked for ProPharma Group, Freelance Pharmacovigilance Service Provider, and medac GmbH.
Jessica is most experienced in industries like Pharmaceutical and Healthcare.
Jessica is most experienced in business areas like Quality Assurance, Audit, and Strategy. Jessica also has some experience in Research and Development and Operations.
Jessica has recently worked in industries like Pharmaceutical.
Jessica has recently worked in business areas like Quality Assurance, Audit, and Strategy.
Jessica attended Ahorn Apotheke for Practical Year (PJ).
The availability of Jessica needs to be confirmed.
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Calculated based on our freelancers’ daily rates as of 25 Aug 2026. Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.
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