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

Nuvalent, Inc.•Cambridge, MA

About The Position

Nuvalent is seeking an Associate Director, Pharmacovigilance (PV) Operations to provide vendor oversight and review of ICSR processing for assigned investigational products. This role ensures compliance with Safety processes and SOPs, manages and analyzes data from the Global Safety Database, and oversees PV operations for Phase 1, 2, & 3 clinical studies. The position involves managing vendor relationships, ensuring timely and accurate execution of safety processes, reviewing adverse event reports, overseeing case workflow, resolving safety case queries, and serving as a Subject Matter Expert (SME) on safety reporting processes and operational aspects of SAE reconciliation. The Associate Director will also contribute to the development and maintenance of SOPs and serve as a resource for other functions within the company regarding pharmacovigilance operational activities.

Requirements

Bachelor’s degree in Nursing, RN, Pharmacy, Pharm D., or other relevant health-care related fields.
8-10 years of progressive drug safety experience in a biotech/pharma company.
Clinical Development experience.
Strong knowledge of current and emerging regulatory requirements including EMA GVP Modules, FDA IND and NDA reporting requirements, ICH, CIOMS
Ability to interpret and follow regulatory guidelines.
Proven knowledge of Good Documentation Practices and cGXPs.
Basic knowledge of MedDRA coding.
Experience in ICSR case-processing and reporting.
Experience working in and with safety databases.
Direct experience managing relationships with service providers or external business partners
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.

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 the 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.