Safety Technology Director
4 weeks ago
We are seeking a highly skilled and experienced Safety Technology Director to join our team at Pharmiweb. As a key member of our organization, you will be responsible for leading the planning and delivery of in-house safety technology, including the safety database, training, maintenance, ongoing support, further development, and replacement with future technologies.
Key Responsibilities:- Lead the planning and delivery of in-house safety technology, including the safety database, training, maintenance, ongoing support, further development, and replacement with future technologies.
- Develop and implement safety analytics and reporting using Oracle Analytics, OBIEE, Power BI, etc.
- 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.
- 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.
- Safety supportive applications (Argus, EDC, automation-focused technology) 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.
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