Associate Director, Pharmacovigilance (PV) Operations (CT Focus)

The Role

Reporting to the Senior Director of Pharmacovigilance (PV) Operations, the Associate Director, PV Operations will provide vendor oversight and review of ICSR processing for assigned investigational products. They will ensure compliance and adherence to Safety processes and SOPs as well as manage and analyze data from the Global Safety Database. This SME will be responsible for PV operations’ role in Phase 1, 2, & 3 clinical studies, inclusive of inspection readiness, reconciliation, SMP maintenance, and site and regulatory authority reporting oversight. They will work in close collaboration with PV physicians and PV scientists on operational safety and case quality issues.

Responsibilities

• Manage and support the relationship with safety vendor(s) to ensure effectiveness, quality and compliance of all outsourced activities.
• Provide Sponsor oversight of operational safety responsibilities, including the timely and accurate execution of the processes defined within the applicable Safety Management plans.
• Participate in daily management, operational oversight and execution of operational safety tasks for assigned Nuvalent clinical programs.
• Review incoming adverse event reports and communications from vendors to determine action required and ensure prompt review, follow-up, and timely submission of expedited safety reports.
• Oversee case workflow (case receipt through submission) between safety vendor and Nuvalent Pharmacovigilance team.
• Ensure safety case queries are resolved as per defined processes (interfacing with safety physicians, clinical operations team, other cross-functional teams within Nuvalent, and clinical vendors, as required) and facilitate case closure within required timelines.
• Serve as PV operations SME on safety reporting processes according to study protocol.
• Participate in the development and maintenance of SOPs, forms, plans, systems, and guidance documents to ensure compliance with all applicable regulatory requirements or guidelines, GVP and industry best practices.
• Serve as resource and contact for other functions within the company for pharmacovigilance operational activities.
• Serve as Pharmacovigilance representative for the operational aspects of the SAE reconciliation.
• Responsible for the development of safety management plans for assigned programs, and associated documents to ensure that study-specific and Regulatory Authority reporting requirements are met and that workflow responsibilities between CROs, and Nuvalent are clearly delineated and adhered to.

Competencies Include

• Excellent written and verbal communication skills.
• Demonstrated communications expertise with the ability to articulate, influence, and work successfully with internal/external stakeholders and within a matrixed environment.
• Ability to plan and handle multiple responsibilities simultaneously and still meet high quality and timeliness standards under pressure.
• Demonstrated contribution to strategy and innovation. Contributes to or leads actionable strategies.
• Demonstrated project management and prioritization capabilities.

Qualifications

• Bachelor’s degree in Nursing, RN, Pharmacy, Pharm D., or other relevant health-care related fields.
• 8-10 years of progressive drug safety experience.