Nuvalent, Inc. · 10 hours ago
Senior Director, Head of Safety Science (Pharmacovigilance)
United States
Full-time
Remote
Director/Executive
$275K/yr - $300K/yr
9+ years expNuvalent is an early-stage company focused on developing selective medicines for cancer patients. The Senior Director, Head of Safety Science will oversee the risk management system for drug safety, collaborating with various teams to ensure patient safety and compliance with regulatory standards.
BiotechnologyLife ScienceTherapeutics
Responsibilities
Safety Signal Detection, Evaluation, and Management
Close collaboration with DSPV Safety Physicians to analyze potential safety issues, including signal detection, signal evaluation and signal management. Collaborates proactively with study teams, cross-functional team members, external business partners and vendors to apply knowledge and analytical skills to problems in specific therapeutic areas
Contribute to signaling and data mining activities utilizing internal and external sources of data
Assist in the evaluation of potential safety issues and quality risk assessment reports
Risk Management and Safety Planning
Responsible for coordinating and developing Risk Management Plans for Nuvalent’s products among multiple stakeholders
Responsible for patient safety evaluation and development of Safety Management Plans
Safety Governance, Meetings, and Reporting
Contribute to activities related to Nuvalent’s safety (governance) meetings, including but not limited to, preparing reports, minutes and meeting documents; ensuring completion of action items; and participating in the discussion of patient safety issues
Manage and support the authoring for aggregate safety reports (e.g., DSUR, PBRER, PADER) in close collaboration with clinical, medical writing and operational functions
Process, SOPs, and DSPV Ways of Working
Contributes to the development of SOPs, work practices and guidelines, forms and templates, and other communications related to risk management and product safety
Responsible for ensuring the global team can anticipate, develop and support improved/consistent scientific ways of working to implement effective PV processes
Analytics and Tools
Establish expertise with data visualization tools (e.g., Spotfire)
Contribute as a member of the DSPV team to scenario planning, strategy analysis, portfolio prioritization, budget management and forecasting
Leadership and Training
Provide management/mentoring of existing Safety Scientists and training for new staff on PV practices and therapeutic area knowledge
Qualification
Required
Degree in a medical or healthcare related discipline like MD, PharmD, RN or PhD
9+ years' experience in Drug Safety/Pharmacovigilance in a pharmaceutical, biotech company or regulatory agency in similar positions
Excellent knowledge of US and EU drug safety regulations, CIOMS and ICH guidelines
Experience with medical drug safety assessments, drug safety surveillance and monitoring activities
Experience with safety data collection and interpretation from clinical trials, literature and post market
Experience with preparation of responses to Regulatory Authorities and experience with IND/NDA submissions and negotiations with Regulatory Authorities as part of marketing approval
Experience with the development and updates to Reference Safety Information, IB, Company Core Data Sheet and local labels
Excellent verbal, written and presentation skills
Benefits
Medical, dental, and vision insurance
401(k) retirement savings plan
Generous paid time off (including a summer and winter company shutdown)
Company
Nuvalent, Inc.
Nuvalent is creating precisely targeted therapies for patients with cancer designed to overcome the limitations of existing therapies for clinically proven kinase targets.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$1.82BKey Investors
Bain Capital Life SciencesDeerfield
2025-11-18Post Ipo Secondary· $500M
2024-09-16Post Ipo Equity· $575M
2023-10-16Post Ipo Equity· $300M
Leadership Team
James Porter
CEO
Alexandra Balcom
Chief Financial Officer
Recent News
MarketScreener
2025-12-16
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