Remote Director, Safety Database Strategy and Analytics

Summary

Join a dynamic early-stage company working to create selective medicines for cancer patients and lead the safety database strategy and analytics as Director.

Requirements

• Strong written/verbal communication skills
• Ability to work in a collaborative environment and build effective working relationships across the organization, and with external stakeholders/vendors
• Detail and process orientated, with excellent project management, problem solving, and organization skills
• Ability to think critically with strong attention to detail
• Demonstrated project management and prioritization capabilities
• 10 years industry experience including 5+ years of experience and understanding of Pharmacovigilance concepts and associated databases
• Bachelor’s degree in a scientific or related technical or related experience

Responsibilities

• Work closely with internal and external business users in Drug Safety and PV management and relevant CRO users to understand requirements and recommend solutions
• Collaborate with vendors and partners
• Serve as the link between Safety/PV business owners, IT, and Quality
• Represent the Drug Safety and PV organization and lead the safety database and analytics activities
• Serve as the business administrator for the Drug Safety and PV Database
• Lead the implementation and documentation of system change requests and updates or creates documents as needed
• Participate in design sessions and provides input on the software solution, architecture, and workflows on behalf of the Drug Safety and PV organization
• Debug complex problems with information systems using a variety of analytical skills, techniques, and resources, in partnership with IT and/or system vendor(s) where applicable
• Participate in validation activities to ensure that quality solutions are delivered to the end user to meet set business requirements as well as conform to company technology principles, architecture, and strategies
• Provide technical expertise on Safety Databases, in partnership with IT and/or system vendor(s) where applicable
• Administer end-user accounts and ensure appropriate access control/permissions
• Provide support to global end-users and ensure understanding of their needs

Benefits

Equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law