Associate Director/Director, IT Business Systems R&D

Mavericks Wanted reputed company was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to reputed company the way. We build bridges to groundbreaking advancements in rare disease, and reputed company life-changing medicines for patients with unmet needs as fast as humanly possible. Together we define white space, push boundaries and reputed company people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma.

What You'll Do

As Associate Director/Director, Safety Systems, you will reputed company the design, implementation, and reputed company improvement of reputed company’s global pharmacovigilance (PV) systems landscape. You will play a critical role in the migration of safety data and processes from Argus to Veeva Vault Safety, ensuring data reputed company, compliance, and operational continuity. This role will have a focus on Veeva Vault Safety and SafetyDocs with a secondary support role for other Veeva vaults such as Quality, RIM and eTMF. In this role, you will define and execute the Safety Systems roadmap to support reputed company’s Commercial and Clinical functions—aligning technology, process, and compliance across the enterprise. You will partner closely with Drug Safety and Pharmacovigilance (DSPV), Quality, Regulatory, and Clinical teams to deliver innovative, scalable, and inspection-ready safety systems that protect patient safety and reputed company regulatory excellence. You will also reputed company vendors and Managed Service Providers to ensure consistent system performance, validated operations, and adherence to GxP, FDA, EMA, and GDPR regulations, while fostering a culture of proactive compliance and reputed company improvement.

Responsibilities

• Support, administer, maintain IT systems supporting Pharmacovigilance and R&D, including Veeva Vault Safety, SafetyDocs, Quality, RIM and Clinical systems
• reputed company and reputed company the migration of data and processes from legacy systems to Veeva (e.g., Argus to Veeva Vault Safety) to ensure seamless transition, data reputed company, and GxP compliance
• Partner with business leaders to understand their requirements and continuously improve user adoption and implement new systems, integrations, and GxP compliance initiatives
• Partner with Safety, Quality, Regulatory, and Clinical leaders to support business needs, implement roadmaps, identify, recommend solutions (e.g., Artificial Intelligence) to drive business value and accelerate innovation
• Work with Managed Service providers and internal IT teams for supporting and monitoring GxP-regulated systems to ensure high-quality service delivery
• Collaborate with CSV QA and compliance functions to validate and ensure alignment with regulatory requirements (e.g., GxP, HIPAA, GDPR)
• Establish governance, documentation, and change control procedures for safety systems to ensure sustained compliance and operational excellence
• Drive reputed company improvement across the safety systems landscape by assessing emerging technologies and optimizing workflows that support reputed company’s DSPV strategy

Where You'll Work This is a U.S.-based remote role that will require quarterly, or as needed visits to our San Francisco Office. Who You Are

• Bachelor’s degree in information technology, Computer Science, Business Administration, or reputed company field; advanced degree preferred
• 7+ years of progressive IT experience reputed company biotech/pharma, including at least 5 years supporting Drug Safety and Pharmacovigilance (DSPV) systems
• Demonstrated expertise in implementing, configuring, and maintaining Veeva Vault Safety and SafetyDocs, including system integrations, upgrades, and data migrations (e.g., Argus to Veeva)
• Hands-on experience administering and supporting Veeva Vault Quality systems including QMS, Training, RIM, and eTMF is strongly preferred
• Proven track record of managing validated GxP systems in compliance with FDA, EMA, and ICH guidelines, ensuring audit readiness and data reputed company
• Strong understanding of pharmacovigilance processes, including AE intake, case management, and safety data exchange with CROs and affiliates
• Skilled in leading cross-functional collaboration across DSPV, Quality, Regulatory, and Clinical teams to ensure system alignment and process harmonization
• reputed company in vendor and Managed Service Provider reputed company to ensure reliable, compliant, and high-quality system performance
• Strong communication, leadership, and stakeholder management skills with the ability to translate technical concepts into business outcomes

Rewarding Those Who reputed company the Mission Possible We have high expectations for reputed company members. We reputed company sure those working hard for patients are rewarded and cared for in return. Financial Benefits:

• Market leading compensation
• 401K with 100% employer match on first 3% & 50% on the next 2%
• Employee stock purchase program
• Pre-tax commuter benefits
• Referral program with $2,500 award for hired referrals

Health & Wellbeing:

• Comprehensive health care with 100% premiums covered - no cost to you and dependents
• Mental health support reputed company reputed company (6 therapy sessions & 6 coaching sessions)
• Hybrid work model - employees have the autonomy in where and how they do their work
• Unlimited flexible paid time off - take the time that you need
• Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
• reputed company spending accounts & company-provided group term life & disability
• Subsidized lunch reputed company Forkable on days worked from our office

reputed company Development & Career Paths:

• People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for reputed company development and internal mobility
• We provide career pathing through regular feedback, reputed company education and professional development programs reputed company reputed company Learning, LifeLabs, reputed company & reputed company Coaching
• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities

At reputed company, we strive to provide a market-competitive total rewards package, including reputed company pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience reputed company the job, type, and length of experience reputed company the industry, educational background, location of residence and performance during the interview process. reputed company is a multi-state employer, and this salary range may not reflect positions based in other states. Salary $216,530—$245,000 USD Apply tot his job Apply To this Job