GCSP Safety Specialist

At Bavarian Nordic, we are committed to saving and improving lives by unlocking the power of the immune system. Our commercial portfolio includes market-leading vaccines against smallpox/mpox, rabies, tick-borne encephalitis, typhoid fever, and cholera. We excel in R&D innovation, manufacturing, and commercialization—working every day to protect people’s health and quality of life and protecting our tomorrow.

We are looking for an experienced GCSP Safety Specialist, Partner Management Lead, to oversee and manage all Pharmacovigilance (PV) obligations agreed with commercial partner of Bavarian Nordic and supports the Director Compliance & Process Excellence, GCSP in other areas of PV operations.

The position reports to the Director Compliance & Process Excellence, GCSP, Swiss QPPV and can be based in either Germany or Switzerland - travel up to ~20% within Europe should be expected.

The role
As our GCSP Safety Specialist, Partner Management Lead, you will play a key role in managing PV partnerships, ensuring that all contractual obligations are fulfilled and that safety data is exchanged efficiently and compliantly. You will act as the process owner for Safety Data Exchange Agreements (SDEAs), maintaining oversight of partner interactions, governance, and compliance performance. In this role, you collaborate closely with internal stakeholders and external partners to support high-quality PV operations and continuous improvement. You will also contribute to broader compliance and process excellence initiatives within GCSP.

Key responsibilities
 

• Establish and maintain SDEAs, ensuring full compliance with contractual PV obligations and effective data exchange

• Lead partner governance, including regular meetings, audit support, and clear communication with internal stakeholders and partners

• Own and maintain SDEA-related processes, systems, and quality documentation, including tracking, reporting, and continuous improvement initiatives

• Manage deviations, CAPAs, and compliance reporting, ensuring transparency towards leadership and the EU-QPPV

• Support wider PV operations through contributions to vendor oversight, compliance activities, training, and SOP/WI development

What you bring
To become a success in this role, you bring a minimum of 5 to 7 years’ experience in pharmacovigilance, preferably in PV operations including partner/SDEA management in the biotechnology/pharmaceutical industry or service providers/Clinical Research Organizations (CROs). It is crucial that you hold knowledge of domestic and international laws, regulations and policies governing pharmacovigilance.

You communicate fluently in English with strong written, verbal, and presentation skills using PV terminology. You are highly proficient in relevant IT tools and database applications and are a self-driven, positive team player who helps to build and sustain high performance and team cohesion.

Most importantly, you thrive in change; your judgment, integrity, and resilience help safeguard patient safety and support our transition from development to full commercialization in a fast-moving, life-science environment.

Why this role
This role offers a unique opportunity to shape and strengthen pharmacovigilance partner management in a global setting, where your work directly supports patient safety and regulatory compliance. You will operate at the intersection of operations, quality, and external collaboration, gaining broad exposure to stakeholders across the organization and with key partners. With ownership of critical processes and systems, you will play an important part in driving consistency, transparency, and continuous improvement. At the same time, you will contribute to a forward-looking team focused on process excellence and innovation within PV.

Application
If you are ready to take on a pivotal role in a growing organization and drive meaningful change in healthcare, apply now and join Bavarian Nordic in our mission to improve health outcomes and foster sustainable growth.

Please note that we do not support any relocation package for this role.

We kindly request that headhunters or recruitment agencies refrain from contacting us regarding this position.

Bavarian Nordic is a global vaccine company with a mission to improve health and save lives through innovative vaccines. We are a preferred supplier of mpox and smallpox vaccines to governments to enhance public health preparedness and have a leading portfolio of travel vaccines. We are headquartered in Denmark and have manufacturing, research, and sales offices across Europe and North America.

Bavarian Nordic is an Equal Opportunity Employer. All qualified applications will receive consideration for employment and will not be discriminated against based on race, color, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

For more information, visit www.bavarian-nordic.com

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Danish vaccine company specializing in infectious disease vaccines including smallpox/mpox and travel health. Based in Kvistgaard.

bavarian-nordic.com