Nuvalent, Inc.
Associate Medical Director, Drug Safety and Pharmacovigilance
Nuvalent, Inc., Cambridge, Massachusetts, us, 02140
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 Medical Director, Pharmacovigilance, the Associate Medical Director, Drug Safety and Pharmacovigilance is responsible for the medical assessment of Individual Case Safety Reports (ICSRs) and other drug safety information. The individual will be responsible for assessing and interpreting safety data from multiple sources, including clinical trials, spontaneous and solicited reports, aggregate, and literature reports. This physician is expected to provide interpretation and summaries of drug safety information and provide input in the generation of safety reports (e.g., DSURs, PSUR and clinical safety assessments). 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:Review, analyze, and compile safety data, and present the resultsContribute 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 reportsSupport of the internal PV Operations functionContribute to ongoing safety surveillance and signal detection efforts, including the identification of safety observations, emergent safety concerns and new safety signals, ensure prompt assessment and communication of confirmed safety signalsServe as a medical resource for the generation and review of clinical trial protocols, informed consent forms (ICFs) and investigator brochures (IBs)Provide medical safety input into the development of Reference Safety InformationContribute to creation or and updates to Risk Management Plans (RMPs) and/or Risk Evaluation and Mitigation Strategies (REMS) and the maintenance of these documentsProvide medical safety and Pharmacovigilance expertise in-house and by consultation with outside vendors for all development programsContribute to the development of Standard Operating Procedures, Working Instructions and other guidance documentsContribute to safety and pharmacovigilance training programsProvide safety training at investigator meetingsPresent safety data and resultsCollaborate with Regulatory Affairs to ensure appropriate reporting of pharmacovigilance and drug safety information to regulatory agencies and prescriber communityCollaborate with Medical Directors and Clinical Research Scientists, and vendor clinical staff who provide medical monitoring support for ongoing clinical trialsDevelop relationships with and capture drug safety information from key groups, including partner companies, physicians, nurses and patient advocacy groupsServe as a subject matter expert for vendors providing drug safety and pharmacovigilance servicesCompetencies Include:
Strong written/verbal communication skills.Ability to work in a collaborative environment and build effective working relationships across the organization, and with external stakeholders/vendorsDetail and process orientated, with excellent project management, problem solving, and organization skills.Ability to think critically with strong attention to detail.Demonstrated project management and prioritization capabilitiesQualifications:
2+ years' experience in Drug Safety / Pharmacovigilance in a pharmaceutical or biotech company, CRO or regulatory agencyMedical Degree (MD) with medical practice experienceWorking knowledge of US and EU drug safety regulations, CIOMS and ICH guidelinesDemonstrated experience with medical drug safety assessments, drug safety surveillance and monitoring activitiesProficiency with medical review of ICSRs, including expectedness assessments, causality assessments, narrative review and generation, generation of Analysis of Similar Event and company comment statements, including benefit-risk assessment.Experience with safety data collection and interpretation originating from clinical trials and other sources (such as literature, solicited and post-marketing environment)Experience with the medical review and preparation of aggregate reports (DSUR, PSUR/PBRER, PADER)Experience with preparation of responses to Regulatory Authorities, preferred experience with IND/NDA submissions and negotiations with Regulatory Authorities as part of marketing approvalExperience with the development and updates to Reference Safety Information, including IB, Company Core Data Sheet (CCDS) and local labelsAbility to build relationships, collaborate and influence across disciplines within Nuvalent and with outside stakeholdersExperience with MedDRA coding, Points to Consider, AoSE, and SMQs
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.
The Role:
Reporting to the Senior Medical Director, Pharmacovigilance, the Associate Medical Director, Drug Safety and Pharmacovigilance is responsible for the medical assessment of Individual Case Safety Reports (ICSRs) and other drug safety information. The individual will be responsible for assessing and interpreting safety data from multiple sources, including clinical trials, spontaneous and solicited reports, aggregate, and literature reports. This physician is expected to provide interpretation and summaries of drug safety information and provide input in the generation of safety reports (e.g., DSURs, PSUR and clinical safety assessments). 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:Review, analyze, and compile safety data, and present the resultsContribute 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 reportsSupport of the internal PV Operations functionContribute to ongoing safety surveillance and signal detection efforts, including the identification of safety observations, emergent safety concerns and new safety signals, ensure prompt assessment and communication of confirmed safety signalsServe as a medical resource for the generation and review of clinical trial protocols, informed consent forms (ICFs) and investigator brochures (IBs)Provide medical safety input into the development of Reference Safety InformationContribute to creation or and updates to Risk Management Plans (RMPs) and/or Risk Evaluation and Mitigation Strategies (REMS) and the maintenance of these documentsProvide medical safety and Pharmacovigilance expertise in-house and by consultation with outside vendors for all development programsContribute to the development of Standard Operating Procedures, Working Instructions and other guidance documentsContribute to safety and pharmacovigilance training programsProvide safety training at investigator meetingsPresent safety data and resultsCollaborate with Regulatory Affairs to ensure appropriate reporting of pharmacovigilance and drug safety information to regulatory agencies and prescriber communityCollaborate with Medical Directors and Clinical Research Scientists, and vendor clinical staff who provide medical monitoring support for ongoing clinical trialsDevelop relationships with and capture drug safety information from key groups, including partner companies, physicians, nurses and patient advocacy groupsServe as a subject matter expert for vendors providing drug safety and pharmacovigilance servicesCompetencies Include:
Strong written/verbal communication skills.Ability to work in a collaborative environment and build effective working relationships across the organization, and with external stakeholders/vendorsDetail and process orientated, with excellent project management, problem solving, and organization skills.Ability to think critically with strong attention to detail.Demonstrated project management and prioritization capabilitiesQualifications:
2+ years' experience in Drug Safety / Pharmacovigilance in a pharmaceutical or biotech company, CRO or regulatory agencyMedical Degree (MD) with medical practice experienceWorking knowledge of US and EU drug safety regulations, CIOMS and ICH guidelinesDemonstrated experience with medical drug safety assessments, drug safety surveillance and monitoring activitiesProficiency with medical review of ICSRs, including expectedness assessments, causality assessments, narrative review and generation, generation of Analysis of Similar Event and company comment statements, including benefit-risk assessment.Experience with safety data collection and interpretation originating from clinical trials and other sources (such as literature, solicited and post-marketing environment)Experience with the medical review and preparation of aggregate reports (DSUR, PSUR/PBRER, PADER)Experience with preparation of responses to Regulatory Authorities, preferred experience with IND/NDA submissions and negotiations with Regulatory Authorities as part of marketing approvalExperience with the development and updates to Reference Safety Information, including IB, Company Core Data Sheet (CCDS) and local labelsAbility to build relationships, collaborate and influence across disciplines within Nuvalent and with outside stakeholdersExperience with MedDRA coding, Points to Consider, AoSE, and SMQs
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.