Drive Pharmacovigilance Technology Excellence: Senior Safety Technology Manager
Lead Global Safety Database Strategy & Innovation at Parexel
Parexel is a leading global clinical research organization (CRO) dedicated to advancing healthcare through innovative clinical research and technology solutions. We are seeking an experienced Senior Safety Technology Manager to provide strategic leadership and hands-on expertise for our global pharmacovigilance safety systems. This role is critical in ensuring the integrity, compliance, and innovation of our safety technology platforms, directly impacting patient safety and regulatory success for our clients worldwide.
This is a remote position requiring fluency in Japanese and English to support our Japan-based resources and clients.
Key Accountabilities
Strategic Technology Leadership & System Ownership
- Lead the setup, configuration, and ongoing support of the Parexel safety database (e.g., Argus, Vault Safety) and associated systems for complex global studies.
- Drive the planning and execution of safety database handovers (client-to-Parexel and Parexel-to-client) for intricate pharmacovigilance projects.
- Design and implement sophisticated integration solutions between safety technologies and other applications (EDC, ERP) to enhance operational excellence.
- Author and review Standard Operating Procedures (SOPs) and controlled documents governing safety technology.
Compliance, Validation & Quality Assurance
- Ensure full adherence to global regulations, including 21 CFR Part 11, EMA Annex 11, GAMP 5, and computer system validation standards.
- Represent Safety Technology Management during internal and external audits and regulatory inspections.
- Lead change management activities in line with the Software Development Life Cycle (SDLC) and Agile methodologies.
- Collaborate with the Global Pharmacovigilance Intelligence Office to proactively meet evolving regulatory requirements.
Issue Management & Advanced Technical Support
- Act as the lead point of contact for complex technical issues, collaborating with IT, vendors, safety staff, and clients to drive resolution.
- Provide advanced-level system administration, including complex configurations, reporting (periodic, ad-hoc), expedited report rules, and client-specific solutions.
- Utilize advanced scripting skills (e.g., SQL) and industry-standard service desk tools to troubleshoot and optimize system performance.
Team Leadership & Client Engagement
- Train, coach, and provide work direction to team members, fostering a culture of continuous improvement and knowledge sharing.
- Develop and deliver presentations to stakeholders and clients on safety technology solutions and service delivery.
- Serve as the direct representative for safety technology in cross-functional teams, ensuring alignment and effective communication.
- Utilize fluent Japanese and English to manage requirements, issues, and solutions with Japan-based internal resources and clients.
Skills & Qualifications
Essential Requirements:
- BA/BSc in Engineering, Computer Science, or related field (Master’s degree preferred).
- 5+ years of hands-on experience in all functional areas of pharmacovigilance safety technology (e.g., Argus, Vault Safety), including configuration, reporting, and support.
- 5+ years of experience working closely with pharmacovigilance operational teams to gather requirements and deliver technology solutions.
- Advanced expertise in system validation, change management, SDLC, and Agile methodologies.
- In-depth knowledge of global regulations: 21 CFR Part 11, EMA Annex 11, GAMP, GVP, and GCP.
- Advanced technical skills in SQL scripting, system integration, and problem management.
- Fluent proficiency in both English and Japanese (verbal and written) is mandatory.
- Proven experience in technical writing, client presentations, and cross-functional leadership.
Preferred Attributes:
- Experience with emerging safety technologies, including AI applications in pharmacovigilance.
- Direct mentorship or training experience (1+ years).
- Demonstrated leadership in system/process improvement initiatives.
- Experience with safety business processes and signal detection tools.
Why Join Parexel?
- Global Impact: Your work ensures the safety of patients worldwide and supports the success of cutting-edge therapies.
- Technology Leadership: Be at the forefront of pharmacovigilance technology, driving innovation in a highly regulated, critical field.
- Career Growth: Clear pathway to leadership roles within technology management, with opportunities for global collaboration.
- Remote Flexibility: Work from anywhere while supporting a diverse, international team and client base.
- Supportive Culture: Join a matrixed environment that values teamwork, professional development, and client-focused excellence.
Ready to lead safety technology for a global CRO and make a tangible impact on patient safety?
Apply now for the Senior Safety Technology Manager position at Parexel.
Parexel is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees as we work together to advance healthcare.
