About Us
At Parexel, we are committed to revolutionizing the way we approach safety technology and pharmacovigilance. As a leader in the industry, we strive to provide innovative solutions that meet the evolving needs of our clients and the pharmaceutical industry as a whole. Our Safety and CTS&L Technology organization is at the forefront of this mission, and we are seeking an exceptional Director, Safety Technology to join our team.
About the Role
We are looking for a highly skilled and experienced Director, Safety Technology to lead our Safety Technology organization. As a key member of our team, you will be responsible for providing oversight and direction for the development and implementation of safety technology solutions that meet the needs of our clients and regulatory agencies. Your expertise will be instrumental in driving process optimization, building technology focused on automation and AI, and achieving audit defensible quality benchmarks within a highly collaborative environment.
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-oriented 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 and Qualifications
We are looking for a highly skilled and experienced individual with a strong background in safety technology, pharmacovigilance, and regulatory compliance. The ideal candidate will possess:
- 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
We are looking for a highly experienced individual with a strong background in safety technology, pharmacovigilance, and regulatory compliance. The ideal candidate will possess:
- 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.
Career Growth Opportunities and Learning Benefits
We offer a range of career growth opportunities and learning benefits to support your professional development and success. As a Director, Safety Technology, you will have the opportunity to:
- Develop and implement innovative safety technology solutions that meet the evolving needs of our clients and the pharmaceutical industry.
- Lead a team of skilled and experienced professionals in the development and implementation of safety technology solutions.
- Collaborate with cross-functional teams to identify and prioritize business needs and develop solutions to meet those needs.
- Participate in training and development programs to enhance your skills and knowledge in safety technology, pharmacovigilance, and regulatory compliance.
- Contribute to the development of our company's safety technology strategy and roadmap.
Work Environment and Company Culture
We offer a dynamic and collaborative work environment that is committed to innovation, excellence, and customer satisfaction. As a Director, Safety Technology, you will be part of a team that is passionate about delivering high-quality safety technology solutions that meet the evolving needs of our clients and the pharmaceutical industry.
Compensation, Perks, and Benefits
We offer a competitive salary and a range of benefits to support your physical, emotional, and financial well-being. As a Director, Safety Technology, you will be eligible for:
- A competitive salary.
- A comprehensive benefits package, including health insurance, retirement savings, and paid time off.
- Opportunities for professional development and career growth.
- A dynamic and collaborative work environment.
- Recognition and rewards for outstanding performance and contributions to the company.
How to Apply
If you are a motivated and experienced individual with a passion for safety technology, pharmacovigilance, and regulatory compliance, we encourage you to apply for this exciting opportunity. Please submit your resume and a cover letter outlining your qualifications and experience. We look forward to reviewing your application.
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