Jessica Dyck
Pharmacovigilance Quality Expert / Graduated Plan Officer (GPO)
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
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Experienced in Pharmaceutical and Healthcare.
Business Area Experience
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Experienced in Quality Assurance, Audit, Strategy, 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
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