Deputy QPPV

Oresund Pharma ApS; København; On-site; DKK 900,000 - 1,100,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

PV experience

ICSR management

GVP knowledge

Regulatory reporting

Cross-functional collaboration

Education

Pharmacy/Medicine/Life sciences degree

Tools

Pheda Safety Database

EudraVigilance

Job description

At Oresund Pharma, we are building a pharmaceutical business where pragmatism, accountability, and quality matter. We operate in a scale-up environment with ambitious growth plans across Europe, and maintaining a robust pharmacovigilance system is essential to supporting both our patients and our business.

We are now looking for an experienced Deputy QPPV to support and strengthen our pharmacovigilance activities. This is a broad role that combines strategic oversight with hands‑on pharmacovigilance operations, offering exposure to the full PV system and the opportunity to influence how we continue to develop our safety processes.

You will work closely with our QPPV as well as external partners and service providers, helping ensure that our pharmacovigilance system remains compliant, effective, and inspection‑ready.

Why this role

The title describes part of the role, but not all of it.

While you will act as Deputy QPPV and support the QPPV in maintaining oversight of our pharmacovigilance system, this is also a highly operational position. We are looking for someone who enjoys being close to the cases, processes, systems, and regulatory requirements that keep a pharmacovigilance system running effectively.

This role offers a unique opportunity to work across the full spectrum of pharmacovigilance activities while building broader responsibility within a growing pharmaceutical company.

Your impact in this role

In this position, you will

• 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

What you will be responsible for

• QPPV Support & PV Oversight
• Support the QPPV in maintaining and developing the pharmacovigilance system
• Act as Deputy QPPV when required
• Maintain and develop the Pharmacovigilance System Master File (PSMF) and related documentation
• Support inspection readiness, audits, CAPAs and compliance activities
• Monitor changes to GVP, EMA guidance and relevant legislation, assessing their impact on the PV system

Operational Pharmacovigilance

• Support the assessment, processing, follow‑up, quality review and reporting of ICSR
• Perform and oversee global and local literature surveillance, including EMA MLM screening
• Work with EudraVigilance and the Pheda Safety Database
• Support safety reconciliations and exchange of safety information with partners
• Maintain oversight of reporting timelines and operational compliance activities

Safety Documentation & Risk Management

• Review and contribute to PSURs/PBRERs, RMPs and other safety‑related documents
• Support signal detection, signal assessment and benefit‑risk evaluation activities
• Prepare, review and update PV SOPs and associated procedures
• Support PV training activities and documentation requirements
• Maintain and support Safety Data Exchange Agreements (SDEAs) and other PV agreements
• Collaborate with distributors, service providers and business partners on PV‑related matters
• Ensure appropriate oversight of outsourced pharmacovigilance activities

What you bring

• Several years of experience within pharmacovigilance
• Practical experience across multiple areas of the PV system
• Solid knowledge of EU pharmacovigilance legislation and Good Pharmacovigilance Practices (GVP)
• Experience with ICSR management and regulatory reporting
• Experience with literature surveillance and literature‑derived cases
• Experience with PSMF maintenance, signal management and safety documentation
• Experience supporting audits, inspections and compliance activities
• A degree in pharmacy, medicine, life sciences or another relevant scientific discipline
• Experience with the Pheda Safety Database is an advantage but not a requirement.

What will help you thrive here

• You enjoy hands‑on pharmacovigilance work and take pride in operational excellence
• You have a strong sense of ownership and follow tasks through to completion
• You are structured, detail‑oriented and comfortable managing multiple deadlines
• You proactively stay updated on regulatory developments and understand their practical implications
• You can balance strategic oversight with operational execution
• You naturally connect the dots and identify issues before they become problems
• You are comfortable working in a growing organisation where responsibilities can evolve

What we offer

• A broad role with exposure to the full pharmacovigilance system
• Close collaboration with the QPPV and significant influence on the development of our PV framework
• An opportunity to expand your responsibilities while remaining close to operational pharmacovigilance
• A dynamic and entrepreneurial environment with short decision‑making paths
• The opportunity to make a tangible impact in a growing pharmaceutical company
• Reporting line: QPPV
• Travel: Limited travel may occur