Associate Director, Pharmacovigilance (PV) Operations

Nuvalent, Inc.•Cambridge, MA

About The Position

Reporting to the Senior Director of Pharmacovigilance (PV) Operations, the Associate Director of PV Operations will provide vendor oversight and review of ICSR processing. 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 the primary point of contact for quality oversight of the case processing vendor. They will work in close collaboration with PV physicians, PV scientists, and PV Excellence on operational safety and case quality issues. The role will expand and evolve in line with Nuvalent’s expansion as we approach potential market authorization.

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.

Nice To Haves

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.
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.