Associate Director, Drug Safety and Pharmacovigilance Scientist
Nuvalent, Inc., Cambridge, MA, United States
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 Head of PV Science, the Associate Director, Drug Safety and Pharmacovigilance Scientist is responsible for assessing and interpreting safety data from multiple sources, including clinical trials, spontaneous and solicited reports, aggregate, and literature reports. This individual is expected to provide interpretation and summaries of drug safety information and provide input in the generation of safety reports (e.g., DSURs, PADERs, PBRERs, and clinical safety assessments). This individual may also support the medical assessment of Individual Case Safety Reports (ICSRs) and other drug safety information. The individual will be an integral part of a group of safety professionals within Nuvalent and will closely collaborate with safety teams in Contract Research Organizations (CROs) and partners. He/she will need to maintain medical knowledge as required by the role, strong and current knowledge of drug safety and pharmacovigilance regulations, pharmacovigilance practices, safety surveillance and risk-management practices.
Responsibilities
Contribute to the generation of aggregate safety reports including development safety update reports, periodic benefit risk evaluation reports, and provide medical input in review of new or existing safety documents to ensure compliance with relevant regulatory requirements, such as protocols, safety summaries and regulatory reports
Contribute to signaling and safety surveillance processes, including the identification of safety observations, emergent safety concerns and new safety signals, ensure prompt assessment and communication of confirmed safety signals
Serve as a medical resource for the generation and review of clinical trial protocols, informed consent forms (ICFs) and investigator brochures (IBs) and the development of Reference Safety Information
Contribute to creation or and updates to Risk Management Plans (RMPs) and/or Risk Evaluation and Mitigation Strategies (REMS) and the maintenance of these documents
Contribute to the development of Standard Operating Procedures, Working Instructions and other guidance documents
Provide safety and pharmacovigilance training programs as required
Collaborate cross functionally (e.g., Reg Affairs, Clin Ops, Clin Science) to ensure pharmacovigilance input
Support the medical assessment of ICSSRs as needed
Support other pharmacovigilance and drug safety responsibilities as assigned
Translate safety data into clinical insights
Adapt visualization tools for safety surveillance
Influence multidisciplinary teams to prioritize patient safety.
Strong ability to build relationships, collaborate and influence across disciplines within Nuvalent and with outside stakeholders
Qualifications
4+ years’ experience in Drug Safety / Pharmacovigilance in a pharmaceutical or biotech company, CRO or regulatory agency
Degree in a medical or healthcare related discipline like MD, PharmD, RN or PhD.
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
Additional Information Nuvalent is committed to fair and equitable compensation practices, aiming to provide employees with competitive total rewards packages.
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 $170,000 — $195,000 USD
Nuvalentprovides 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.
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The Role Reporting to the Head of PV Science, the Associate Director, Drug Safety and Pharmacovigilance Scientist is responsible for assessing and interpreting safety data from multiple sources, including clinical trials, spontaneous and solicited reports, aggregate, and literature reports. This individual is expected to provide interpretation and summaries of drug safety information and provide input in the generation of safety reports (e.g., DSURs, PADERs, PBRERs, and clinical safety assessments). This individual may also support the medical assessment of Individual Case Safety Reports (ICSRs) and other drug safety information. The individual will be an integral part of a group of safety professionals within Nuvalent and will closely collaborate with safety teams in Contract Research Organizations (CROs) and partners. He/she will need to maintain medical knowledge as required by the role, strong and current knowledge of drug safety and pharmacovigilance regulations, pharmacovigilance practices, safety surveillance and risk-management practices.
Responsibilities
Contribute to the generation of aggregate safety reports including development safety update reports, periodic benefit risk evaluation reports, and provide medical input in review of new or existing safety documents to ensure compliance with relevant regulatory requirements, such as protocols, safety summaries and regulatory reports
Contribute to signaling and safety surveillance processes, including the identification of safety observations, emergent safety concerns and new safety signals, ensure prompt assessment and communication of confirmed safety signals
Serve as a medical resource for the generation and review of clinical trial protocols, informed consent forms (ICFs) and investigator brochures (IBs) and the development of Reference Safety Information
Contribute to creation or and updates to Risk Management Plans (RMPs) and/or Risk Evaluation and Mitigation Strategies (REMS) and the maintenance of these documents
Contribute to the development of Standard Operating Procedures, Working Instructions and other guidance documents
Provide safety and pharmacovigilance training programs as required
Collaborate cross functionally (e.g., Reg Affairs, Clin Ops, Clin Science) to ensure pharmacovigilance input
Support the medical assessment of ICSSRs as needed
Support other pharmacovigilance and drug safety responsibilities as assigned
Translate safety data into clinical insights
Adapt visualization tools for safety surveillance
Influence multidisciplinary teams to prioritize patient safety.
Strong ability to build relationships, collaborate and influence across disciplines within Nuvalent and with outside stakeholders
Qualifications
4+ years’ experience in Drug Safety / Pharmacovigilance in a pharmaceutical or biotech company, CRO or regulatory agency
Degree in a medical or healthcare related discipline like MD, PharmD, RN or PhD.
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
Additional Information Nuvalent is committed to fair and equitable compensation practices, aiming to provide employees with competitive total rewards packages.
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 $170,000 — $195,000 USD
Nuvalentprovides 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.
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