Ultragenyx
Executive Director, Safety Science, Global DSPV
Ultragenyx, Novato, California, United States, 94949
Overview
Executive Director, Safety Science, Global DSPV Responsibilities
Provides DSPV leadership in support of the development, registration, and life-cycle management for assigned Ultragenyx portfolio of products Guides, coaches, managers assigned Safety Science professionals to ensure their professional development and advancement Lead/contribute to the safety aspect of interactions with Regulatory authorities worldwide (FDA, EMA etc.) at type C, B, pre-BLA/MAA/NDS meetings, Scientific Advice, Advisory Committee meetings, or other scientific advice forums for portfolio products Provide DSPV leadership to support Ultragenyx Commercial organization global launch activities for portfolio products Manages pre- and post-marketing safety surveillance activities in compliance with ICH guidelines, Good Pharmacovigilance Practices (GVP), and all applicable global health authority regulations, guidance and best practices Builds partnerships with key senior stakeholders from other functions to ensure strategic and operational business goals are met through the sharing of knowledge, expertise and the provision of appropriate resources Liaises and negotiates with global regulatory authorities as needed for all aspects pertaining to drug safety, including resolution of key regulatory-safety issues and to expedite approvals of products Maintains awareness of global regulatory environment, facilitates interpretation of PV regulations, and assesses impact of changes on business and PV system Proactively manages critical and urgent safety issues, taking leadership for the DSPV contribution for portfolio products Develop and implement department policies, processes and SOPs Support inspection readiness activities, internal audits, and external inspections for Safety Science Contribute to the generation and maintenance of Pharmacovigilance Agreements (PVAs) Requirements
MD required Minimum of 12 years in a senior/advanced PV Science role within the pharmaceutical/biotechnology industry, with at least 5 years in supervisory capacity Rare disease experience in all phases of biologic, small molecule, mRNA and gene therapy drug development preferred including IND/CTA, NDA/BLA/MAA experience with success interacting with Regulatory authorities, Advisory Committees, or other scientific advice forums Strong people management skills, willingness to develop team and help others succeed Extensive working knowledge of global PV/safety regulatory environment including ICH, international regulations, guidelines, standards of Good Pharmacovigilance Practices (GVP) including best practices and implementation Working knowledge of industry standard safety databases (ARGUS), Regulatory databases, and other electronic data capture systems Strong medical science analytical reasoning skills with experience in the principles and techniques of data analysis, proficient in data analysis software and data presentation; interpretation and clinical relevance Excellent interpersonal communication, and influencing skills (up and down); success influencing executives and senior level scientific management as well as external representation of company MedDRA trained and working knowledge of MedDRA and WHO Drug dictionaries Real-world supporting PV audits and health authority inspections Domestic / international travel may be required Compensation
The base pay range listed in the job posting is $324,000.00/yr - $400,300.00/yr. The typical annual salary range for this full-time position is listed below and may be adjusted based on geographic location. This position is eligible for annual bonus and equity incentives. Benefits
Generous vacation time and public holidays observed by the company Volunteer days Long term incentive and Employee stock purchase plans or equivalent offerings Employee wellbeing benefits Fitness reimbursement Tuitions sponsoring Professional development plans Benefits vary by region and country Company information
Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing talentacquisition@ultragenyx.com. See our CCPA Employee and Applicant Privacy Notice. See our Privacy Policy. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Seniority level
Director Employment type
Full-time Job function
Management and Manufacturing
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Executive Director, Safety Science, Global DSPV Responsibilities
Provides DSPV leadership in support of the development, registration, and life-cycle management for assigned Ultragenyx portfolio of products Guides, coaches, managers assigned Safety Science professionals to ensure their professional development and advancement Lead/contribute to the safety aspect of interactions with Regulatory authorities worldwide (FDA, EMA etc.) at type C, B, pre-BLA/MAA/NDS meetings, Scientific Advice, Advisory Committee meetings, or other scientific advice forums for portfolio products Provide DSPV leadership to support Ultragenyx Commercial organization global launch activities for portfolio products Manages pre- and post-marketing safety surveillance activities in compliance with ICH guidelines, Good Pharmacovigilance Practices (GVP), and all applicable global health authority regulations, guidance and best practices Builds partnerships with key senior stakeholders from other functions to ensure strategic and operational business goals are met through the sharing of knowledge, expertise and the provision of appropriate resources Liaises and negotiates with global regulatory authorities as needed for all aspects pertaining to drug safety, including resolution of key regulatory-safety issues and to expedite approvals of products Maintains awareness of global regulatory environment, facilitates interpretation of PV regulations, and assesses impact of changes on business and PV system Proactively manages critical and urgent safety issues, taking leadership for the DSPV contribution for portfolio products Develop and implement department policies, processes and SOPs Support inspection readiness activities, internal audits, and external inspections for Safety Science Contribute to the generation and maintenance of Pharmacovigilance Agreements (PVAs) Requirements
MD required Minimum of 12 years in a senior/advanced PV Science role within the pharmaceutical/biotechnology industry, with at least 5 years in supervisory capacity Rare disease experience in all phases of biologic, small molecule, mRNA and gene therapy drug development preferred including IND/CTA, NDA/BLA/MAA experience with success interacting with Regulatory authorities, Advisory Committees, or other scientific advice forums Strong people management skills, willingness to develop team and help others succeed Extensive working knowledge of global PV/safety regulatory environment including ICH, international regulations, guidelines, standards of Good Pharmacovigilance Practices (GVP) including best practices and implementation Working knowledge of industry standard safety databases (ARGUS), Regulatory databases, and other electronic data capture systems Strong medical science analytical reasoning skills with experience in the principles and techniques of data analysis, proficient in data analysis software and data presentation; interpretation and clinical relevance Excellent interpersonal communication, and influencing skills (up and down); success influencing executives and senior level scientific management as well as external representation of company MedDRA trained and working knowledge of MedDRA and WHO Drug dictionaries Real-world supporting PV audits and health authority inspections Domestic / international travel may be required Compensation
The base pay range listed in the job posting is $324,000.00/yr - $400,300.00/yr. The typical annual salary range for this full-time position is listed below and may be adjusted based on geographic location. This position is eligible for annual bonus and equity incentives. Benefits
Generous vacation time and public holidays observed by the company Volunteer days Long term incentive and Employee stock purchase plans or equivalent offerings Employee wellbeing benefits Fitness reimbursement Tuitions sponsoring Professional development plans Benefits vary by region and country Company information
Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing talentacquisition@ultragenyx.com. See our CCPA Employee and Applicant Privacy Notice. See our Privacy Policy. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Seniority level
Director Employment type
Full-time Job function
Management and Manufacturing
#J-18808-Ljbffr