Do you want to play a key role in ensuring patient safety and regulatory compliance across Europe?
Join us in a senior pharmacovigilance role where you will help shape and oversee our PV system – and step in as a key decision-maker when it matters.

The opportunity

As our Deputy QPPV, you will support the Qualified Person for Pharmacovigilance (QPPV) in maintaining oversight of our pharmacovigilance system and ensuring compliance with EU legislation and Good Pharmacovigilance Practices (GVP) for the medicinal products for which the company acts as the marketing authorization holder (MAH).

You will also contribute to oversight of products managed through commercial partnership, and parallel distribution and parallel import (PD/PI). This role combines system ownership, partner oversight/management, and regulatory accountability in a highly regulated environment.

When needed, you will act as a delegate to the QPPV for the categories mentioned above, ensuring continuity of oversight and serving as a key point of contact for health authorities such as the European Medicines Agency (EMA).

We would like you to:

• Act as deputy QPPV and step in during absences, taking on delegated responsibilities

• Maintain an inspection-ready Pharmacovigilance System Master File (PSMF)

• Support the creation, development, implementation, and continuous improvement of our PV system, including SOPs and working instructions

• Ensure robust processes for the collection, assessment, and reporting of adverse events in line with strict regulatory timelines

• Oversee pharmacovigilance activities performed by internal teams and external partners

• Support signal detection activities and maintenance of Risk Management Plans (RMPs)

• Contribute to PV audits and inspections, including preparation and follow-up (CAPAs)

• Monitor PV compliance through KPIs and quality metrics

You will also:

• Support PV oversight for commercial partner products, ensuring obligations defined in pharmacovigilance agreements (PVAs) are implemented and followed

• Contribute to establishing and maintaining safety data exchange agreements (SDEAs)

• Ensure compliance for PV activities related to parallel distribution and parallel import products

• Coordinate safety data exchange with partners and support reconciliation activities

About you, our new colleague

You bring strong pharmacovigilance experience and are comfortable operating at system level, with a solid understanding of regulatory requirements and partner setups.

We imagine that you:

• Have 7–10 years of pharmacovigilance experience, preferable experience from a QPPV office or similar oversight role

• Have strong knowledge of EU pharmacovigilance legislation and GVP guidelines

• Have experience with PV system oversight and regulatory compliance

• Ideally have worked with commercial partners and/or parallel import/distribution setups

• Hold a relevant scientific degree (e.g. biological, pharmaceutical, or medical sciences)

• Are fluent in English; additional EU languages (e.g. Dutch) are an advantage

You are structured and analytical, with a strong sense of accountability. You understand the critical importance of regulatory timelines, where missed deadlines can have direct compliance implications.

You are comfortable working under pressure and making decisions in a complex, regulated environment.

You take ownership of your responsibilities and hold yourself to high standards, while contributing to an open and transparent working environment where continuous improvement is part of how we operate.

What we offer

You will take on a key role in a growing international company where pharmacovigilance is central to our operations. You will work closely with senior stakeholders and have real influence on how our PV system is shaped and maintained.

This is an opportunity to combine regulatory expertise, system ownership, and business interaction in a role with high visibility and impact.

Are you interested?

If you want to apply, please use the apply link and attach your resumé.

We look forward to receiving your application!

Moving Healthcare. Moving You.

In Abacus Medicine Group, you’ll experience the power of Moving Healthcare. With our change mindset, we're moving the industry and improving healthcare as we broaden access to medicine.

But it's not just about moving healthcare, it's about Moving You. You’ll be part of a caring community of more than 1,300 people across the World. With us, you will be valued, empowered, and have a direct impact on driving change. Let's access the future of medicine and make a difference together. Your move.

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