Contractor - Manager, Pharmacovigilance LATAM

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 do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t 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 work. Ultimately, 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 and personally, come join our team.

Position Summary:

ultrainnovative – Tackle rare and dynamic challenges

The LATAM Pharmacovigilance Manager is a member of the Global Drug Safety and Pharmacovigilance (DSPV) Department and will support the Head Pharmacovigilance (PV) Latin American (LATAM) to develop, implement, maintain the LATAM PV System to meet regulatory and Good Pharmacovigilance (GVP) requirements, to ensure compliance and inspection/audit readiness for a growing portfolio of Ultragenyx products.  

The LATAM Pharmacovigilance Manager will report directly to and be line‑managed by Head PV LATAM and 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 and maintain effective 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 and GVP guidelines. 

• Support the development, maintenance, and update of LATAM Detailed Description of Pharmacovigilance System (DDPS) . 

• Maintain in‑depth knowledge of Ultragenyx marketed products in LATAM, including safety profiles and emerging safety concerns with potential public health impact. 

• Contribute to timely and accurate submission of PV deliverables to regulatory authorities, including ICSRs, aggregate safety reports, safety queries, RPV/deputy notifications,  

• Support and perform quality review of ICSR follow‑up activities across LATAM.  

• Reconcile local submission compliance with PV service providers. 

• Support local 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 of PV‑related activities conducted by local Call Centers and Patient Support Programs (PSPs). 

• Support and participate in LATAM and other PV inspections and audits, including preparation, execution, documentation, and follow‑up of findings and CAPAs. 

• Prepare and deliver adverse event (AE) reporting training for Ultragenyx employees, PV service providers and other business partners and support the development and implementation of tools and local systems to optimize PV activities across the LATAM region. 

Requirements:

1. Health care professional, resident of Brazil, with a university degree (i.e., third level qualification) in life sciences or allied health fields required (Medical Doctor, Pharmacist, Nurse); a post-graduation in biotechnology will be a plus, other experience will be considered. 
2. Minimum 5 years Pharmacovigilance experience, preferably in rare disease. 
3. Excellent oral and written communication skills in English (required), Spanish (required). 
4. Requires a high level of initiative, independence and accountability. 
5. 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 skills a must. 
6. Regulatory databases (Gateways) knowledge, Veeva Vault, experience with industry‑standard safety database platforms (ARGUS), other electronic data capture systems and a differential Smartsheet management experience. 
7. MedDRA and WHO Drug trained and working knowledge. 
8. Willingness to be onsite as needed; some national/international travel may be required; willingness to travel including overnight trips.  

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  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 talentacquisition@ultragenyx.com.

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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: talentacquisition@ultragenyx.com.