Description

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.

Domaines d’expertise

Langues

Allemand
Bilingue ou natif
Anglais
Capacité professionnelle complète
Espagnol
Capacité professionnelle limitée
Français
Notions

Préférences en matière de lieu de travail

En télétravail uniquement

Travaille majoritairement à distance

medac GmbH
Pharmakovigilanz Managerin
INDUSTRIE PHARMACEUTIQUE
janvier 2018 - Aujourd'hui (8 ans et 5 mois)
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.

Soyez le premier à recommander Jessica

Contribuez à la réussite de ce freelance en partageant votre expérience de collaboration avec lui.

Agatha Frydrych

Backend Java Software Engineer

4.7

(3)

Baptiste Duhen

Fullstack developer

4.6

(4)

Amed Hamou

Senior Lead Developer

(2)

Audrey Champion

Web developer

4.3

(3)

S’inscrire pour les voir

Pharmacist
Technischen Universität Braunschweig
2013

Autre

Jessica Dyck

Pharmacovigilance Expert

À propos de Jessica

Expériences

Recommandations

Ces profils de freelance correspondent également à vos critères

Formations

Compétences

Catégories