At Veeva, we build enterprise cloud technology that powers the biggest names in the pharmaceutical, biotech, consumer goods, chemical amp; cosmetics industries. Our customers make vaccines, life-saving medicines, and life-enhancing products that make a difference in everyday lives. Our technology has transformed these industries; enabling them to get critical products and services to market faster. Our core values, Do the Right Thing, Customer Success, Employee Success, and Speed, guide us as we make our customers more efficient and effective in everything they do.
The RoleVeeva is looking for Drug Safety and Pharmacovigilance experts to join the Professional Services team and support implementations of our Vault Safety solution. We want innovative thinkers with deep domain expertise who are ready to challenge the status quo with new technology.As a key member of our Professional Services team, the Consultant Safety amp; PV SME will work side-by-side with customers and our senior consultants to implement Vault Safety. In this role, you will support the overall delivery of Vault Safety for our customers. You will define and drive business processes, support the project team in delivering the solution, and guide our customers throughout the implementation programs.What You'll Do
- Support life sciences customers in the rapid configuration and implementation of Vault Safety.
- Execute workshops and lead customer discussions of the Vault Development Cloud.
- Lead gap analyses, workshop preparation and delivery, requirements gathering, configuration, validation, and customer training.
- Gather customer functional and technical requirements to support business processes; translate requirements into system configuration.
- Provide subject matter expertise on Drug Safety and Pharmacovigilance for customers and project teams.
- Represent Safety Professional Services across multiple engagements and workstreams (e.g. solution design and configuration, data migration, systems integration, etc.).
- Ensure customer success from beginning to end of the engagement life cycle.
Requirements
- 7+ years of life sciences industry experience, with the majority spent in the Drug Safety and Pharmacovigilance domain and experience in a consulting function.
- Knowledge of Drug Safety and Pharmacovigilance processes and regulations.
- Should have hands-on with Drug Safety Databases like ARISg or ARGUS.
- Should have good knowledge of PMDA/MHLW reporting requirements. CSUJ, J-PSUR, MHLW lone listing reports.
- Should understand MedDRAj, JDD dictionaries, Line listing
- Good understanding of global safety reporting concepts
- Should be able to understand and interpret regulations and updates to regulations from GreenBook
- Proven ability to collaborate with diverse stakeholders and ensure delivery to a high degree of satisfaction.
- Ability to act with speed to understand business requirements, create corresponding solution designs, and willingness to roll up your sleeves to design and Vault Safety.
- Exposure to life sciences compliance and computer systems validation requirements.
- Ability to travel 25-50%,
- Bachelor’s degree or equivalent required.
Nice to Have
- Proven track record supporting high impact global system implementation programs as a consultant, business, or IT lead, and/or business sponsor.
- Direct experience with systems such as Oracle Argus, ARISg, and/or other drug safety applications
- Life science, computer science, or related Degree
- SaaS/Cloud experience
- Experience in services delivery management and/or systems implementation
- Locality to major life sciences customer hub (Tokyo, Osaka)
#LI-Remote
Veeva’s headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world.