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 Vice President of DSPV, the Sr. Manager, PV Operations Excellence is a key member of our pharmacovigilance team and is responsible for maintaining PV compliance with regulatory reporting compliance, presentation of safety data, managing standard PV procedures and assisting in the oversight of vendor services and PV agreements. The individual will be an integral part of a group of safety professionals and will closely collaborate internally cross functionally (e.g., Clinical Operations, Quality Assurance, Regulatory Affairs) and with external safety teams in Contract Research Organizations (CROs) and partners. The candidate will need to maintain knowledge as required by the role, strong and current knowledge of drug safety and pharmacovigilance regulations, pharmacovigilance practices.
Responsibilities:
• Support/Develop GVP SOPs, strategies and processes, review & training of PV SOPs
• Support the GVP- vendor audit, internal audit, and inspection procedures and address GVP-audit observations
• Present the GVP activities during regulatory inspections
• Review and provide QA support for maintenance of PSMF and SDEA
• Identify and escalate critical GVP findings to DSPV Senior Management
• Track Key DSPV Performance Indicators (KPIs)
• Develop, manage, implement, and improve internal Quality Management System for DSPV.
• Initiate deviations and CAPAs, perform investigations and root cause analysis
• Oversee generation and review of documents used in GVP activities
• Provide consultation in interpretation of GVP regulations/guidelines
Competencies Include:
• Foster a culture of empowerment, collaboration, and a focus on patient impact
• Encourages collaboration, innovation and new ideas while integrating information from various sources
• Demonstrated ability to develop and foster relationships with internal and external stakeholders
• Drives for results - creates and nurtures a performance-based culture of continuous improvement, addressing concerns and conflict proactively
• Demonstrated ability to create departmental capabilities, processes, and procedures to ensure alignment with desired outcomes
• Highly effective presentation, communication, emotional intelligence, and interpersonal skills
Qualifications:
• Minimum Bachelor's degree required preferably in healthcare or life sciences or the equivalent combination of relevant education or professional experience
• 6+ years of relevant experience within the biotechnology or pharmaceutical industry, including at least one (1-2) years of PV quality and compliance experience (GVP)
• Developing Standard Operating Procedure (SOP) in GVP field
• Experience in compliance and quality management systems including developing procedures, deviation/CAPA management, management of KPIs, regulatory inspections, and PV audits
• Working knowledge and understanding of global regulations for safety and PV including FDA, EMA, and ICH guidelines.
• Working knowledge of PV processes for individual case processing, signal detection and evaluation, aggregate safety reporting, regulatory intelligence, as well as clinical study safety management
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.
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