Why Join Us
Be a hero for our rare disease patients
At Ultragenyx we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to achieve this goal our vision is to lead the future of rare disease medicine. For us this means going where other biopharma companies wont go challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science applying a novel rapid development approach making innovative medicines at fair and reasonable prices and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them.
Our commitment and care for patients extends to our people so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth so employees can thrive in all areas of their lives in and outside of we want to be an organization where we would be proud for our family friends and children to work.
If you want to have a meaningful impact do the best work of your career and grow a lot both professionally andpersonally come join our team.
Position Summary:
ultrainnovative Tackle rare and dynamic challenges
TheLATAM PharmacovigilanceManageris a member of the Global Drug Safety and Pharmacovigilance (DSPV) Departmentand will supporttheHead Pharmacovigilance (PV) Latin American (LATAM)to develop implement maintain the LATAMPV Systemto meet regulatory and Good Pharmacovigilance (GVP)requirements to ensure compliance and inspection/audit readiness foragrowing portfolio of Ultragenyx products.
The LATAM PharmacovigilanceManagerwill report directly to and belinemanagedbyHead PV LATAMand will work closely with and be supported by the Global DSPV team.
Work Model:
Flex: This role will typically require onsite work 2-3 days each week or more depending on business needs.
Responsibilities:
- Develop andmaintaineffective relationships with key stakeholders including vendors license partners and other internal and external third parties.
- Support the establishment maintenance and continuous improvement of the LATAM PV system to ensure compliance with local regulatory requirements andGVPguidelines.
- Support the development maintenance and update of LATAM DetailedDescription ofPharmacovigilance System (DDPS).
- Maintainindepthknowledge of Ultragenyx marketed products in LATAM including safety profiles and emerging safety concerns with potential public health impact.
- Contribute totimelyandaccuratesubmission of PV deliverables to regulatory authorities including ICSRs aggregate safety reports safety queries RPV/deputy notifications
- Supportand perform qualityreview ofICSRfollowupactivities across LATAM.
- Reconcile local submission compliance with PV service providers.
- Supportlocal literature surveillance and regulatory intelligence activities.
- Provide input into LATAM PBRERs and RMPs including risk minimization measures and support their local implementation and oversight.
- Support oversight ofPVrelatedactivities conducted by local Call Centers and Patient Support Programs (PSPs).
- Support andparticipateinLATAMand otherPV inspections and audits including preparation execution documentation andfollowupof findings and CAPAs.
- Prepare and deliver adverse event (AE) reporting training for Ultragenyx employeesPV service providers and other businesspartnersandsupport the development and implementation of tools and local systems tooptimizePV activities across the LATAM region.
Requirements:
- Health care professional residentofBrazil with a university degree (i.e. third level qualification) in life sciences or allied health fields(Medical Doctor Pharmacist Nurse); a post-graduation in biotechnology will be a plus other experience will be considered.
- Minimum5yearsPharmacovigilance experience preferably in raredisease.
- Excellent oral and written communication skills in English (required) Spanish (required).
- Requiresa high levelof initiativeindependenceand accountability.
- Ability to navigate fast paced and dynamic work environment; ability to manage and prioritize multiple projects and demands simultaneously with ability to adjust to changing priorities and work effectively under pressure; organizational and prioritization skillsa must.
- Regulatory databases(Gateways)knowledge Veeva Vaultexperience withindustrystandardsafety database platforms(ARGUS) other electronic data capture systems and a differential Smartsheet management experience.
- MedDRA andWHO Drug trainedandworking knowledge.
- Willingnessto be onsite as needed; some national/internationaltravel may be; willingness to travel including overnight trips.
#LI-CK1 #LI-Remote
Full Time employees across the globe enjoy a range of benefits including but not limited to:
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
Tuition sponsoring
Professional development plans
* Benefits vary by region and country
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 us at .
See ourCCPA Employee and Applicant Privacy Notice.
See our.
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.
Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us may be directed to:.
Required Experience:
Manager
Why Join UsBe a hero for our rare disease patientsAt Ultragenyx we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to achieve this goal our vision is to lead the future of rare disease medicine. For us this means goi...
Why Join Us
Be a hero for our rare disease patients
At Ultragenyx we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to achieve this goal our vision is to lead the future of rare disease medicine. For us this means going where other biopharma companies wont go challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science applying a novel rapid development approach making innovative medicines at fair and reasonable prices and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them.
Our commitment and care for patients extends to our people so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth so employees can thrive in all areas of their lives in and outside of we want to be an organization where we would be proud for our family friends and children to work.
If you want to have a meaningful impact do the best work of your career and grow a lot both professionally andpersonally come join our team.
Position Summary:
ultrainnovative Tackle rare and dynamic challenges
TheLATAM PharmacovigilanceManageris a member of the Global Drug Safety and Pharmacovigilance (DSPV) Departmentand will supporttheHead Pharmacovigilance (PV) Latin American (LATAM)to develop implement maintain the LATAMPV Systemto meet regulatory and Good Pharmacovigilance (GVP)requirements to ensure compliance and inspection/audit readiness foragrowing portfolio of Ultragenyx products.
The LATAM PharmacovigilanceManagerwill report directly to and belinemanagedbyHead PV LATAMand will work closely with and be supported by the Global DSPV team.
Work Model:
Flex: This role will typically require onsite work 2-3 days each week or more depending on business needs.
Responsibilities:
- Develop andmaintaineffective relationships with key stakeholders including vendors license partners and other internal and external third parties.
- Support the establishment maintenance and continuous improvement of the LATAM PV system to ensure compliance with local regulatory requirements andGVPguidelines.
- Support the development maintenance and update of LATAM DetailedDescription ofPharmacovigilance System (DDPS).
- Maintainindepthknowledge of Ultragenyx marketed products in LATAM including safety profiles and emerging safety concerns with potential public health impact.
- Contribute totimelyandaccuratesubmission of PV deliverables to regulatory authorities including ICSRs aggregate safety reports safety queries RPV/deputy notifications
- Supportand perform qualityreview ofICSRfollowupactivities across LATAM.
- Reconcile local submission compliance with PV service providers.
- Supportlocal literature surveillance and regulatory intelligence activities.
- Provide input into LATAM PBRERs and RMPs including risk minimization measures and support their local implementation and oversight.
- Support oversight ofPVrelatedactivities conducted by local Call Centers and Patient Support Programs (PSPs).
- Support andparticipateinLATAMand otherPV inspections and audits including preparation execution documentation andfollowupof findings and CAPAs.
- Prepare and deliver adverse event (AE) reporting training for Ultragenyx employeesPV service providers and other businesspartnersandsupport the development and implementation of tools and local systems tooptimizePV activities across the LATAM region.
Requirements:
- Health care professional residentofBrazil with a university degree (i.e. third level qualification) in life sciences or allied health fields(Medical Doctor Pharmacist Nurse); a post-graduation in biotechnology will be a plus other experience will be considered.
- Minimum5yearsPharmacovigilance experience preferably in raredisease.
- Excellent oral and written communication skills in English (required) Spanish (required).
- Requiresa high levelof initiativeindependenceand accountability.
- Ability to navigate fast paced and dynamic work environment; ability to manage and prioritize multiple projects and demands simultaneously with ability to adjust to changing priorities and work effectively under pressure; organizational and prioritization skillsa must.
- Regulatory databases(Gateways)knowledge Veeva Vaultexperience withindustrystandardsafety database platforms(ARGUS) other electronic data capture systems and a differential Smartsheet management experience.
- MedDRA andWHO Drug trainedandworking knowledge.
- Willingnessto be onsite as needed; some national/internationaltravel may be; willingness to travel including overnight trips.
#LI-CK1 #LI-Remote
Full Time employees across the globe enjoy a range of benefits including but not limited to:
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
Tuition sponsoring
Professional development plans
* Benefits vary by region and country
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 us at .
See ourCCPA Employee and Applicant Privacy Notice.
See our.
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.
Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us may be directed to:.
Required Experience:
Manager
View more
View less
Job Location:
Monthly Salary:
Posted on:
7 hours ago
Vacancies:
1 Vacancy
