Principal Pre-Sales Engineer, Pharmacovigilance & Drug Safety

You will act as a subject-matter expert in drug safety and pharmacovigilance, with an initial focus on Oracle Life Sciences Safety products (Safety One Intake, Safety One Argus, Safety One Empirica).

You will be working closely with customers and teams across sales, product, bid management and technical functions, and you will understand customers' safety challenges and translate them into compelling solution strategies, demonstrations and value propositions. This is a consultative, customer-facing role combining deep domain expertise with technology, problem-solving and presentation skills.

We are open to candidates based in Belgium, Czechia, Denmark, Finland, Ireland, Norway or the United Kingdom. The successful candidate may be based in any one of these countries.

What you'll do

• Lead discovery with pharmacovigilance, safety operations, IT, regulatory and quality stakeholders to understand processes, challenges, compliance needs and transformation priorities.

• Translate customer requirements into end-to-end Oracle Safety solution approaches and clearly articulate their business and operational value.

• Deliver tailored demonstrations, workshops, proof-of-concepts and technical presentations, while helping maintain effective and up-to-date demonstration environments.

• Advise customers on pharmacovigilance processes and best practices, including case processing, medical review, signal management, reporting, regulatory submissions and inspection readiness.

• Partner with account teams on opportunity strategy, qualification, complex RFP/RFI responses, technical win themes and customer objections.

• Explain integration, security, data migration, validation and deployment considerations in collaboration with internal technical specialists.

• Support commercial discussions around solution scope, implementation considerations, delivery risks and opportunities to expand existing customer relationships.

• Represent Oracle in customer meetings, executive briefings and industry events, while bringing market and customer insight back into Product and go-to-market teams.

• Willingness to travel approximately 25% within EMEA for customer engagements.

Required qualifications

•     Minimum 10 years of experience in pharmacovigilance, gained within the pharmaceutical industry, CROs, Life Sciences consulting or safety technology providers

•     Strong working knowledge of pharmacovigilance safety databases, such as Oracle Argus Safety or similar solutions

•     Extensive knowledge and understanding of global pharmacovigilance processes and regulations, including ICH guidelines, GVP, adverse event case management, expedited reporting, and aggregate reporting

•     Customer facing experience in a consulting, implementation, advisory, customer success, pre-sales or account management role

•     Experience presenting complex software solutions to both business and technical audiences

• A strong understanding of AI/ML in PV context would be an advantage

• Ability to run structured discovery sessions and convert business needs into solution requirements

• Fluent written and spoken English; proficiency in an additional European language would be an advantage

• Excellent verbal, written, and stakeholder-management skills

• Ability to work independently while collaborating effectively across sales, product, services, and partner teams

Preferred qualifications

• Solution demonstration and presentation experience would be an advantage

• Sales process acumen and customer relationship experience would be an advantage

• Understanding of signal detection methodology in pharmacovigilance 

• Experience with safety-system implementation, validation, upgrades, migrations, integrations, or managed services.

• Familiarity with cloud/SaaS architecture, APIs, data integration, and identity/security concepts.

• Advanced degree in life sciences, pharmacy, medicine, nursing, biomedical sciences, or a related discipline.

• Experience working within ‘virtual’ teams, often across geographies and cultures