Senior Director, Head of Safety Science (Pharmacovigilance)
About The Position
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 SVP, Drug Safety and Pharmacovigilance, the Senior Director, is responsible for supporting the development and implementation of a risk management system for risk detection, risk assessment and risk minimization for investigational and marketed products. Will oversee risk management plan activities including signal tracking maintenance, ad hoc Health Authority requests and the planning and preparation for aggregate safety reports including DSURs, PADERs and PBRERs for Nuvalent’s products.
Requirements
- 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
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
Benefits
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
