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Jessica DyckJD

Jessica Dyck

Pharmacovigilance Expert

€1,000/day
Hamburg, DE
3-7 years
Pharmacovigilance
Pharmacovigilance Audit
Drug Safety Agreement
EU GVP Module 4 Specialist
CAPA Management

Average response time: 1 hour

About Jessica

I am a highly experienced pharmacovigilance expert specializing in PV quality management. With a strong background in EU GVP compliance, I offer a wide range of services, including PV audits, CAPA management, risk-based audit systems, SOP development, and more. My focus is on delivering high-quality, cost-efficient solutions for pharmaceutical companies and service providers. Fluent in German and English, I provide tailored support for international teams and ensure regulatory compliance in every project. I am committed to helping companies improve their pharmacovigilance processes and meet industry standards with precision and reliability.
Consulting and Audits
Biotechnologies
Health and Wellness
Pharmaceuticals

  • German

    Native or bilingual

  • English

    Fluent

  • Spanish

    Conversational

  • French

    Basic

Remote only
Primarily works remotely

Experience

  • medac GmbH
    Pharmakovigilanz Managerin
    PHARMACEUTICALS INDUSTRY
    January 2018 - Today (8 years and 5 months)
    Wedel, SH, Germany
    Pharmacovigilance Audits: Conducting and following up on audits in compliance with EU GVP Module IV.
    Risk-Based Audit Planning: Developing and implementing risk-based strategies to prioritize audits.
    Drug Safety Agreements (DSAs): Negotiating, drafting, and managing agreements, including contracts for post-marketing studies.
    Partner and Affiliate Management: Qualification, monitoring, and oversight of international PV partners.
    PSMF / PSSF: Preparing, maintaining, and ensuring compliance with EU-GVP requirements.
    ICSR and Signal Management: Identifying, evaluating, and managing safety signals and individual case safety reports.
    SOPs and Validated Databases: Developing and maintaining standard operating procedures and implementing validated PV databases.
    Regulatory Inspections: Preparing for, supporting, and following up on regulatory inspections.
    Project Management: Leading and coordinating projects within the pharmacovigilance field.

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Education

  • Pharmacist
    Technischen Universität Braunschweig
    2013

Skill set

Signal Management
Literature screening
PV-Quality
Inspection Preparation and Support
Creation and Maintenance of PSMF/PSSF
Developing and maintaining Standard Operating Procedures (SOPs)
Reconciliation
Risk based audit planing
Microsoft365
MedDRA Coding
Document Management Systems
EudraVigilance
Project Management
Root Cause Analysis
Due Diligence
Partner Management
ICH-Guidelines
Regulatory Compliance (EU GVP)
Negotiation Skills
Report writing and documentation
Presentation Skills
Team training and Workshops
Client consulting and support
Intercultural Communication
Stakeholder Management
Time management
Problem solving skills
Deviation Management
Risk-based process design
Pharmacovigilance compliance monitoring

Categories

  • Other