Senior PV Solutions Architect – Pharmacovigilance

Oracle; Norway; On-site; NOK 1,100,000 - 1,700,000; Full time

Job summary

Oracle Life Sciences is seeking a pharmacovigilance and safety domain expert to guide customers in safety data management, case processing, signal management and regulatory submissions across Oracle Safety products. You will translate customer needs into end‑to‑end solution strategies, deliver demonstrations, and work with sales, product and technical teams.

You will travel approximately 25% in EMEA, engage with customers across multiple countries, and contribute to proposals, RFPs, and

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

Responsibilities

• 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

Skills

Pharmacovigilance expertise

Customer facing

Consulting experience

Presentation skills

Stakeholder management

English fluency

Education

Advanced degree in life sciences or related

Tools

Oracle Argus Safety

Safety databases

Job description

Oracle Life Sciences is seeking a pharmacovigilance and safety domain expert to guide customers in safety data management, case processing, signal management and regulatory submissions across Oracle Safety products. You will translate customer needs into end‑to‑end solution strategies, deliver demonstrations, and work with sales, product and technical teams.

You will travel approximately 25% in EMEA, engage with customers across multiple countries, and contribute to proposals, RFPs, and