Associate Director, Pharmacovigilance – PV Operations

Role Overview

• 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.
• Monitor performance (metrics, other reports) of the safety vendor and the quality output of the ICSRs; provide appropriate feedback and training.
• Monitor key performance indicators of case processing and present findings to Head of PV and cross-functional stakeholders.
• Participate in daily management, operational oversight and execution of operational safety tasks for assigned Nuvalent clinical programs.
• As needed. 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.

Requirements

• Bachelor’s degree in nursing, RN, Pharmacy, Pharm D., or other relevant health-care related field.
• 8-10 years of experience in a biotech/pharma company.
• Direct experience managing relationships with service providers or external business partners
• 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.

Benefits

• medical, dental, and vision insurance
• 401(k) retirement savings plan
• generous paid time off (including a summer and winter company shutdown)