Director, Safety Database Strategy and Analytics
The Company:
With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building.
The Role:
Reporting to the Senior Vice President, Pharmacovigilance, the Director, Safety Database Strategy and Analytics is responsible for leading and managing safety database needs including ongoing maintenance and reporting, implementation of system upgrades. Serving as the link between the internal and external business users, IT, and the database vendor, the Director, Safety Database Strategy and Analytics is responsible for leading safety database evaluation and associated signaling tools. As the technical expert on the safety database, the Director serves as an advisor to Drug Safety and PV leadership on safety database issues.
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.
- 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.
Qualifications:
- 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.
- Oncology experience is preferred.