24 Sep
|
Spadtek Solutions
|
India
24 Sep
Spadtek Solutions
India
: Veeva Vault Safety Developer (Remote)
Level: Mid-level (3-5 years' experience)
Job Type:Contract
Domain: Life Sciences, Pharmacovigilance / Drug Safety
Role Summary
We re hiring for one of the top IT services companies.
SPADTEK Solutions is proud to collaborate with leading IT organizations to source exceptional talent for their contracts & full-time positions.
Client/Implementation Partner is a globally recognized IT services and consulting company, trusted by Fortune 500 clients and enterprises worldwide. With a solid presence across cloud, data engineering, AI, and digital transformation and is known for delivering cutting-edge solutions that drive business growth and innovation.
Working on enterprise-scale projects with global clients.
Exposure to next-gen technologies across cloud, data, and digital platforms.
A culture that values continuous learning, collaboration, and career growth.
Being part of a company consistently ranked among the top IT employers.
If you are an experienced professional seeking a long-term career opportunity with one of the industry s most respected names, this is your chance to join top IT services company through SPADTEK Solutions.
We are looking for a Veeva Vault Safety Developer to configure, extend, and support Veeva Vault Safety within a regulated life sciences environment. You will work with functional analysts, business stakeholders, and technical teams to turn business requirements into working configurations, workflows, and integrations. The work follows a formal SDLC and GxP-compliant delivery standards. Deep clinical knowledge is not required, but you should be comfortable working in validated systems.
Key Responsibilities
- Configure Veeva Vault Safety:
object types, fields, page layouts, document and object lifecycles, workflows, roles, and security.
- Support Vault Safety modules such as Case Intake, Case Processing, Reporting/Distribution, and Safety.AI, as applicable to the project.
- Develop and maintain integrations and data flows using Vault REST APIs, VQL, Vault Loader, and (where needed) the Vault Java SDK.
- Support E2B(R3) regulatory and partner submissions, and configure MedDRA/WHODrug dictionaries and reporting rules.
- Work with functional analysts to interpret requirements, review specifications, and estimate effort.
- Participate in all SDLC phases: design, build, unit testing, SIT/UAT support, deployment, and hypercare.
- Prepare and maintain configuration specifications, test scripts and evidence, traceability, and release documentation to support CSV.
- Manage changes through sandbox ? validation ? production using change control, and support release impact assessments for Veeva's quarterly releases.
- Troubleshoot defects and support incidents; perform root cause analysis.
- Follow GxP, 21 CFR Part 11, EU Annex 11, and internal SOP requirements.
Required Qualifications
- 3-5 years of hands-on experience with Veeva Vault,
with a strong focus on Vault Safety (Vault Quality or Clinical experience is also acceptable if combined with safety exposure).
- Solid experience with Vault configuration: lifecycles, workflows, atomic security, object and field setup, and reporting/dashboards.
- Working knowledge of Vault APIs, VQL, and data loading or migration tools.
- Understanding of SDLC (Agile and/or Waterfall), including change management and test documentation.
- Exposure to regulated life sciences environments (pharma, biotech, CRO) and validation practices (GAMP 5, CSV/CSA).
- Basic understanding of pharmacovigilance concepts: ICSRs, case lifecycle, seriousness and causality, expedited reporting, MedDRA.
- Strong communication skills, with the ability to collaborate with functional analysts and explain technical topics to non-technical stakeholders.
- Bachelor's degree in Computer Science, IT, Life Sciences, or a related field.
Preferred / Nice-to-Have
- Veeva Vault certifications (e.g., Vault Administrator, Vault Safety).
- Experience with Vault Java SDK, custom actions, and triggers.
- Experience with E2B(R3) and safety gateways (e.g., EMA EVWEB, FDA ESG).
- Experience migrating from legacy safety systems (Argus, ArisG) to Vault Safety.
- Integration experience (MuleSoft, Informatica, Boomi, or similar) with EDC, CTMS, or PV partner systems.
- Familiarity with JIRA, Confluence, ALM/Kneat, or similar tools.
- Scripting knowledge (Python, SQL, JavaScript).
Soft Skills
- Clear written and verbal communication
- Ability to work independently on defined tasks while collaborating with senior in-house resources
- Attention to detail and documentation discipline
- Comfort working across time zones and with distributed teams
📌 Veeva Vault Safety Developer (India)
🏢 Spadtek Solutions
📍 India