The PV Operations Lead will be responsible for supporting technology solutions for the Global Patient Safety, Quality Assurance and Regulatory Affairs groups at Vertex. In this role, they will partner with platform owners and business teams to support and maintain systems that enable business strategic capabilities to support the company's growth. Additionally, they will maintain reliable, scalable, and compliant systems, delivery and enhancements that provides opportunities for developing and implementing innovative solutions and integrations that easily support current and evolving business needs. These systems include PV, Quality and Regulatory focused solutions such as Argus (Global Safety Database (GSD)), Empirica (Safety Signal Detection), PV Reports, Veeva RIM, QMS, and Quality Docs as well as core technology solutions such as Amazon Web Services (AWS), ServiceNow, and Power BI.
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to
HR@insightglobal.com.
To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy:
https://insightglobal.com/workforce-privacy-policy/ .
* Strong PV experience specifically with Argus Safety (Upgrade, Migration, Implementation etc)
* Change Management experience
* Experience documenting requirements and working with IQ/OQ/PQ Testing
* 5+ years of Safety/PV, Quality, Regulatory technology (like Argus, Veeva RIM, QMS, etc.) experience
* Good understanding of ICH E2B R2 AND Latest R3 regulations
* Experience with working with Gateway Submissions and Electronic Submissions
* Hands on experience with database/SQL and Windows platforms
* Relevant IT experience in the pharmaceutical domain
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.