Technical Business Analyst for Pharmacovigilance - Job ID: 1493

Ascendis Pharma - Palo Alto, CA

Full-time - Senior

Remote - Palo Alto, CA

Merchant Wholesalers, Nondurable Goods

About the position

The Technical Business Analyst for Pharmacovigilance at Ascendis Pharma plays a crucial role in digitalizing the pharmacovigilance team, focusing on patient safety through technology. This position involves working with the Argus Safety System and collaborating with global teams to support the commercialization of marketed products. The role requires a strong analytical mindset and the ability to thrive in a fast-paced, innovative environment.

Responsibilities

• Conduct workshops with Pharmacovigilance business executives to design the necessary configuration of the Argus Safety Suite.
• Review business processes and perform impact/gap analysis.
• Develop technical requirement specifications for Argus Product configuration including reporting rules, workflows, E2B, and aggregate reporting.
• Implement reporting solutions using Safety Reporting Applications like Oracle Analytics in conjunction with Oracle Argus.
• Perform ad-hoc queries of the database and work with vendors to develop validated queries/reports.
• Create reporting solutions with reporting platforms and services, ensuring accurate and relevant report outputs.

Requirements

• Bachelor's degree in a relevant field such as natural science, IT, Digital, or Engineering.
• 5+ years of experience in a related role within the pharmaceutical or biotechnology industry.
• Extensive understanding of pharmacovigilance solutions and industry best practices.
• Technical expertise in migration, customization, upgrades, and reporting tools.
• Competent in GxP regulations and aware of 21CFR part 11 regulations.
• Experience in managing change control and generating CAPA documentation.
• Experience supporting internal and external audits for pharmacovigilance systems.
• Solid grasp of Oracle Argus Safety system or similar PV reporting platforms.

Nice-to-haves

• Experience working in an agile team environment.
• Familiarity with Argus Analytics and other pharmacovigilance systems.
• Ability to think long-term while acting pragmatically in the short term.

Benefits

• Paid parental leave
• Health savings account
• AD&D insurance
• Disability insurance
• Health insurance
• Dental insurance
• Flexible spending account
• Work from home options
• Employee assistance program
• Vision insurance
• 401(k) matching
• Employee discount programs
• Pet insurance