The Role:

Reporting to the Senior Medical Director, Pharmacovigilance, the Associate Director, Pharmacovigilance 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 serve as the primary point of contact and liaison for the CRO which performs case processing activities for Nuvalent. They will work in close collaboration with pharmacovigilance physicians on operational safety issues and cross-functional team members. This individual will ensure that case processing vendors are following the safety management plan and providing high quality ICSRs, through close oversight and collection and analysis of KPIs.

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 all 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 clinical operations team and clinical vendors, as required) and facilitate case closure within required timelines.
• Monitor performance (metrics, other reports) of the safety vendor and the quality output of the ICSRs; provide appropriate feedback and training.
• 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.
• Ensure procedural deviations are appropriately documented and corrective action plans arising from audits and inspections are put in place.
• Responsible for the operational aspects of safety inspection readiness activities in collaboration with department leadership.
• Serve as resource and contact for other functions within the company for pharmacovigilance operational activities.
• Monitor key performance indicators of case processing and present findings to Head of PV and cross-functional stakeholders.
• Obtain/provided regularly scheduled listings of AEs/SAEs for safety reviews.
• Serve as Pharmacovigilance representative for the operational aspects of the SAE reconciliation process.
• Responsible for the development of safety management plans, 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 too.

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 field.
• 7 years of progressive drug safety experience in a biotech/pharma, Medical Device or a CRO company.
• Clinical Development experience.
• Working knowledge of ICH/GCP Guidelines and US CFR 314.80, 312.32; MedDRA and WHO_DRUG dictionaries.
• 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.