Principal Pre-Sales Engineer, Pharmacovigilance & Drug Safety

Oracle; Finland; Hybrid; EUR 110,000 - 160,000; Full time

Job summary

Oracle is seeking a senior pharmacovigilance specialist to act as a subject-matter expert for Safety products. You will collaborate with customers across sales, product, and services to translate safety challenges into compelling Oracle Safety demonstrations and value propositions.

The role involves travel across EMEA and delivering end-to-end PV solution strategies. You will lead discovery sessions, tailor demonstrations, and support RFP responses while staying current with regulations and best

Qualifications

• Minimum 10 years of experience in pharmacovigilance within pharma, CROs, or safety tech providers.
• Strong knowledge of PV safety databases such as Oracle Argus Safety or similar.
• Deep understanding of global PV processes and regulations (ICH, GVP, AE case management, reporting).
• Customer-facing experience in consulting, advisory, or pre-sales roles.
• Experience presenting complex software solutions to business and technical audiences.
• Knowledge of AI/ML in PV context is advantageous.
• Ability to run structured discovery sessions and translate needs into requirements.
• Fluent English; additional European language is a plus.
• Excellent communication and stakeholder management; independent with cross-team collaboration.

Responsibilities

• Lead discovery with PV, safety ops, IT, regulatory and quality stakeholders to identify needs and priorities.
• Translate customer requirements into Oracle Safety solution approaches and articulate business value.
• Deliver tailored demos, workshops, PoCs and maintain updated demo environments.
• Advise on PV processes, case processing, signal management, reporting, and inspections readiness.
• Collaborate with account teams on strategy, RFP/RFI responses and customer objections.
• Explain integration, security, data migration, validation, and deployment considerations with technical teams.
• Support commercial discussions on scope, delivery risks, and expansion opportunities.
• Represent Oracle in customer meetings and industry events; share market insights with product teams.
• Willingness to travel ~25% within EMEA for customer engagements.

Skills

PV expertise

Global PV processes

Stakeholder management

Consulting experience

Solution presentation

AI/ML in PV (adv.)

Discovery facilitation

Business requirements to tech

English fluency

Cross-functional collaboration

Education

Advanced degree in life sciences or related

Tools

Oracle Argus Safety

Safety system implementations

Job description

Job Description

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

About Us

Only Oracle brings together the data, infrastructure, applications, and expertise to power everything from industry innovations to life‑saving care. And with AI embedded across our products and services, we help customers turn that promise into a better future for all. Discover your potential at a company leading the way in AI and cloud solutions that impact billions of lives.

True innovation starts when everyone is empowered to contribute. That's why we're committed to growing a workforce that promotes opportunities for all with competitive benefits that support our people with flexible medical, life insurance, and retirement options. We also encourage employees to give back to their communities through our volunteer programs.

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Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans' status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.