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Malt Strategy
Malt Strategy
Jessica DyckJD

Jessica Dyck

Pharmacovigilance Expert

1.000 €/Tag
Hamburg, DE
3-7 Jahre
Pharmacovigilance
Pharmacovigilance Audit
Drug Safety Agreement
EU GVP Module 4 Specialist
CAPA Management

Durchschnittliche Reaktionszeit: 1h

Über 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.
Beratungs- und Prüfungsdienstleistungen
Biotechnologien
Gesundheit & Wellness
Pharmazeutika

  • Deutsch

    Muttersprachlich oder zweisprachig

  • Englisch

    Verhandlungssicher

  • Spanisch

    Konversationssicher

  • Französisch

    Grundkenntnisse

Nur remote
Führt Projekte hauptsächlich remote aus

Projekt- und Berufserfahrung

  • medac GmbH
    Pharmakovigilanz Managerin
    PHARMAZEUTISCHE INDUSTRIE
    Januar 2018 - Heute (8 Jahre und 5 Monate)
    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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Ausbildung und Abschlüsse

  • Pharmacist
    Technischen Universität Braunschweig
    2013

Fähigkeiten

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

Kategorien

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