Director, Safety Database Strategy And Analytics

Summary

Join Nuvalent, a dynamic early-stage company focused on developing cancer treatments, as their Director, Safety Database Strategy and Analytics. Reporting to the SVP of Pharmacovigilance, you will lead and manage safety database needs, including maintenance, reporting, and system upgrades. You will serve as the liaison between internal/external users, IT, and the database vendor, leading database evaluations and utilizing signaling tools. As the technical expert, you will advise Drug Safety and PV leadership. This role requires strong collaboration, problem-solving, and technical expertise in safety databases. The ideal candidate possesses extensive experience in pharmacovigilance and a scientific background.

Requirements

• 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
• 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

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

Preferred Qualifications

Oncology experience