Safety Specialist - Technical Lead

Roles & Responsibilities:

Monitor, manage, and ensure delivery of projects in a deadline-driven environment.
Author Technical SDLC deliverables
Technical assistance for testing preparation and implementation of enhancements
Contribute to the creation of operational support documentation
Drive technical delivery and accountability of internal staff as well as vendors and third-party project managers
Enable early identification and appropriate escalation of risks and issues that require assistance, attention, or management resolution
Presentation capability to build current to be architecture for Architecture Review Board
Solution architect with exposure working with corporate EA and following their guidelines
Lead capable to interact with internal as well as external vendor

Experience:

8+ years' experience as a technical lead/solution architect
Experience working with SaaS and cloud (AWS) platforms
Prior experience working with Clinical R&D Safety system/ Pharmacovigilance (PV) applications e.g. ARISg or similar
Technical understanding of Safety system in term of infrastructure, and integration
Experience working with SaaS vendor to manage various SDLC deliverables with GxP validated applications
Strong interpersonal and teamwork skills as well as solid analytical and creative problem-solving skills
Ability to operate effectively in a matrix environment; team player yet able to work independently with minimal direction.
Excellent oral and written communication skills; able to organize and present ideas in a convincing and compelling manner.
Capable of multi-tasking across projects; highly organized
Pharmaceutical or Clinical Research Organization industry experience
Exposure with SaaS to Cloud migration is preferable
Clinical system development experience preferable