**The Company:**With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. 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 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
Additional Information:
Nuvalent is committed to fair and equitable compensation practices, aiming to provide employees with competitive total rewards packages. The targeted salary range reflects what Nuvalent reasonably and in good faith expects to offer for this position at the time of posting, but the final salary determination may be within or outside this range based on various factors, including, but not limited to, experience, skills, education, and market factors. The range will be reviewed regularly and is subject to change. Nuvalent also offers a comprehensive benefit package to support our employees at each stage of their career, financial, health, and well-being journey, including medical, dental, and vision insurance, 401(k) retirement savings plan, generous paid time off (including a summer and winter company shutdown), and much more. Annual Salary Range
$185,000—$205,000 USD
Nuvalent provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law. ---
Nuvalent is aware that many companies are dealing with fraudulent job postings on third-party employment search sites and/or individual(s) or entities claiming to be employees of such companies. Those involved are offering fraudulent employment opportunities to applicants, often asking for sensitive personal and financial information, and using such information for criminal activities. Please be advised that all legitimate correspondence from a Nuvalent employee will come from "@nuvalent.com" email accounts. Automated system response emails from our Greenhouse applicant tracking system come from a “no-reply@greenhouse.io” email address. There are no variations of these email addresses and Nuvalent would not request personal and/or financial information via email. Job opportunities would only be extended after a completed job application is submitted by a candidate and a thorough interview process including 1:1 and/or group interviews via phone, video conferencing and/or in-person. If you believe you have been contacted by anyone misrepresenting themselves as an employee of Nuvalent, please contact Nuvalent at 857-357-7000. Thank you.
