Director, Safety Technology
As a Leader in Parexels 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 Parexels 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
Apply Now
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
Apply Now