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Director, Safety Technology United States of America, Remote Additional Locations: Remote - United States of America Job IDR0000025903 CategoryMedical Sciences

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About this Role

As a Leader in Parexel’s Safety and CTS&L Technology organization, you will provide oversight and direction for the Safety Technology organization. Enable the team and its members to grow in their career and deliver forward thinking technology solutions and support to Parexel’s Safety Operations and Clients by establishing process optimization, building technology focused on automation and AI, and achieving audit defensible quality benchmarks within a highly collaborative environment. Provide input and expertise into current and future safety technology and proactively identify opportunities for improvements and efficiencies in the delivery and support of safety technology.

Key Accountabilities:

Safety Technology Leadership

• Act in a leadership role for the planning and delivery of in-house safety technology, including the safety database (currently Oracle Argus Safety SaaS 8.4.1, Oracle Analytics), extending to training, maintenance, ongoing support, further development, and replacement with future technologies

• Have a passion and knowledge for driving Safety Analytics and Safety Reporting using Oracle Analytics, OBIEE, Power BI, etc

• Strong knowledge of Apex Development (preferably in Safety solutions) or similar.

• Possess a strong focus on vision specifically focused on ways to automate all Safety processes and solutions.

• Provide support and input into client audits and regulatory inspections relating to safety technology provided by Parexel

• Provide input and direction for current and future safety technology, including the safety systems roadmap.

• Drive Business Case development for new technology solutions

• Provide Oversight to large technology projects to ensure successful delivery on time and on budget.

• Act as a point of contact both internally and with external clients to develop programs and processes to meet requirements of both contracts and regulatory agencies.

Staff Management

• Recruit, retain and develop a skilled, experienced and motivated team

• Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced, and objective manner

• Demonstrate excellent leadership skills within the function or location. This includes taking an active role in functional or location activities (e.g., management meetings or project support) as appropriate

• Participate in formal staff review processes e.g., performance and salary reviews to corporate standards and timescales.

Client Management

• Ensure client and business needs are met and that all initiatives and support tasks are optimally resourced with suitably experienced staff

• Oversee Client and/or Software vendor relationships

• Oversee and participate in project bids, including client presentations and business review meetings and providing input to resource allocation and pricing

Skills:

• Exceptional interpersonal, verbal, and written communication skills

• Client focused approach to work

• Strong ability to manage virtual teams and motivate direct reports

• Ability to manage Managers and Direct Reports.

• Expert analytical and problem-solving skills

• Exceptional organizational and customer service skills

• Willingness to lead in a matrix environment and to value the importance of teamwork

• Lead a team working through problem management. Be accountable for the implementation of the solution(s)

• Comprehensive knowledge of relevant Safety software and systems.

• Experience of emerging pharmacovigilance safety technology, including AI

• Advanced experience of standard SDLC processes including change management

• Proactive identification of new work and new learnings

• Lead multiple and varied tasks with enthusiasm and prioritize workload for others using standard Project Management methodologies

• Expert knowledge and practical application of computer system regulations and guidance in the pharmaceutical industry including: 21 CFR Part 11, EMA Annex 11, GAMP

• Advanced knowledge of Pharmacovigilance roles, standards, and practices

• Advanced knowledge of GVP and GCP

Knowledge and Experience:

• Safety Supportive Applications (Argus, EDC, Automation focused technology) - 12+ years of experience in all functional areas of safety technology including all secondary tools and processes

• Drug Safety and Pharmacovigilance Business Processes - 12+ years of experience working closely with operational teams to manage issues, gather and document requirements, and deliver solutions

• Propose and Deliver System/Process Improvements - 5+ years with demonstrated delivery of improvement initiatives

• Leadership Representation - 5+ years as a point of contact and directly responsible individual working with cross-functional teams as a safety technology representative

• Communication Skills - Extremely strong, Fluent in English; demonstratable ability to write and deliver clear presentations to senior stakeholders, clients and conference attendees

• Safety Analytics - 3+ years’ experience driving Safety Analytics

• Apex Development - 3+ years working with Apex / Managing Apex development

#LI-REMOTE

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.