Deputy QPPV & PV Operations Leader

Oresund Pharma ApS; København; Presencial; DKK 900 000 - 1 100 000; Tempo integral

Resumo da oferta

Oresund Pharma ApS is seeking an experienced Deputy QPPV to support and strengthen pharmacovigilance activities across Europe. The role blends strategic oversight with hands-on PV operations, ensuring system compliance and inspection readiness.

You will work closely with the QPPV and external partners to maintain an effective PV framework, contributing to safety documentation, audits, and continuous improvement within a growing pharmaceutical company.

Qualificações

• Several years of experience within pharmacovigilance and a broad PV background.
• Hands-on experience with ICSR management and regulatory reporting.
• Solid knowledge of EU pharmacovigilance legislation and GVP.
• Ability to maintain inspection readiness and PV governance.

Responsabilidades

• Support the QPPV in maintaining oversight of the pharmacovigilance system.
• Act as Deputy QPPV during periods of QPPV absence.
• Ensure compliance with pharmacovigilance legislation, GVP requirements and reporting obligations.
• Help maintain inspection readiness and strong PV governance.
• Contribute to continuous improvement of PV processes, documentation and quality systems.
• Serve as a key link between internal stakeholders, service providers and business partners.
• Operational pharmacovigilance: assess, process, follow-up, quality review and reporting of ICSR.
• Safety documentation: review PSURs/PBRERs, RMPs and other safety documents.

Conhecimentos

PV experience

ICSR management

GVP knowledge

Regulatory reporting

Cross-functional collaboration

Formação académica

Pharmacy/Medicine/Life sciences degree

Ferramentas

Pheda Safety Database

EudraVigilance

Descrição da oferta de emprego

Oresund Pharma ApS is seeking an experienced Deputy QPPV to support and strengthen pharmacovigilance activities across Europe. The role blends strategic oversight with hands-on PV operations, ensuring system compliance and inspection readiness.

You will work closely with the QPPV and external partners to maintain an effective PV framework, contributing to safety documentation, audits, and continuous improvement within a growing pharmaceutical company.