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Technical Business Analyst -Pharmacovigilance

YOH Services LLC
United States, California, Palo Alto
Jan 03, 2025
Technical Business Analyst -Pharmacovigilance Category: Clinical Operations Employment Type: Direct Hire Reference: BH-380534 As a vital member of the Global IT team, the Technical Business Analyst will play a key role in advancing the digital transformation of our pharmacovigilance operations! This is an exciting opportunity to work in a dynamic and fast-paced environment, collaborating with diverse, cross-functional teams to achieve outstanding results. This position will join the Global Pharmacovigilance IT Product Team, known for their dedication to delivering exceptional support to internal drug safety teams! The team utilizes cutting-edge technologies to align with business strategies. The environment is collaborative, fast-moving, and results-driven. Title: Technical Business Analyst- Pharmacovigilance Salary: $150-180K DOE Location: Palo Alto, CA Type: Full time, On-Site/Hybrid Responsibilities: Able to balance short-term, practical solutions with long-term strategic planning to ensure Facilitate workshops with Pharmacovigilance business leaders to design and configure the Argus Safety Suite, analyze business processes, identify gaps, and create technical requirements specifications. Design and deliver reporting solutions using various reporting platforms, ensuring accurate data extraction, manipulation, and management for insightful, reliable reports. Configure key components of the Argus system, including reporting rules, workflows, E2B, aggregate reporting, and EDI functionality. Set up and configure aggregate safety reports such as PADER, DSUR, CSPR, and others. Implement reporting solutions utilizing safety reporting tools like Oracle Analytics in conjunction with Oracle Argus. Execute ad-hoc database queries and collaborate with external vendors to create validated reports and queries as needed. Requirements: Comfortable in a flexible, innovation-driven environment. Self-starter with the ability to spot opportunities and take action to drive progress. Collaborative team player with a strong analytical mindset and a can-do attitude. Academic degree, such as a bachelor's in Science, IT, digital technologies, engineering, or another relevant field. 5+ years of experience in a related role within the pharmaceutical, biotechnology, or a similar industry. A deep understanding of pharmacovigilance (PV) solutions, industry best practices, and various business processes or technology designs within a product/technology family. Experience handling a wide range of complex tasks that require independent judgment to implement PV products and technology to address business needs. Technical proficiency in migration, customization, upgrades, and reporting tools. Knowledgeable in GxP regulations and familiar with 21CFR part 11 compliance. Experience managing change control processes and creating/generating CAPA documentation when necessary. Expertise in supporting internal and external audits and inspections related to PV systems. Familiarity with key technical areas such as Argus safety solutions, Argus Analytics, pharmacovigilance systems, Argus product configuration, data migration, computer system validation (CSV), GAMP5, E2B R2/R3, and system implementation. Strong understanding of Oracle Argus Safety or other PV reporting platforms like ArisGlobal LifeSphere MultiVigilance. Proven experience working in an agile environment, continuously improving workflows and practices. Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply. Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process. Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply. Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process. For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.