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 Systems is looking for Pharmacovigilance lead with Drug Safety amp; Pharmacovigilance experience to join the Professional Services team and lead the teams in implementing Vault Safety solution.Candidates for this position will gain consulting experience, innovative technology-forward thinking, exposure to setting up optimum and efficient Drug Safety business processes, and knowledge of working with exceptional cloud-based solutions.In this role, you will work as a domain expert in implementing our Vault Safety Solution. Work as a team player and participate in workshops for defining and documenting the business requirements, and design the solution accordingly.What You'll Do
- Gather and document business, functional/non-functional requirement during workshops
- Design the solution based on the requirements, define thorough use case scenarios and develop test scripts accordingly
- Work with configuration team and develop the solution
- Be the point of contact for the functional, regulatory guidance for internal and external stakeholders.
- Lead the user acceptance testing
Requirements
- Overall 12+ years of life sciences industry experience
- At least 3+ years of consulting experience in the life sciences industry
- At least 5+ years of Drug Safety and Pharmacovigilance domain experience.
- 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
- Strong Business Analysis skills.
- Ability to travel 25-50%
Nice to Have
- Life Science, computer science or related degree
- SaaS/Cloud experience
- 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.