Contractor - Manager, Pharmacovigilance LATAM

Ultragenyx Pharmaceutical

3d•Hybrid

About The Position

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, and 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.

Requirements

Health care professional, resident of Brazil, with a university degree (i.e., third level qualification) in life sciences or allied health fields (Medical Doctor, Pharmacist, Nurse).
Minimum 5 years Pharmacovigilance experience, preferably in rare disease.
Excellent oral and written communication skills in English (required), Spanish (required).
Requires a high level of initiative, independence and 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 skills a must.
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.
MedDRA and WHO Drug trained and working knowledge.
Willingness to be onsite as needed; some national/international travel may be required; willingness to travel including overnight trips.

Nice To Haves

A post-graduation in biotechnology will be a plus, other experience will be considered.

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.