Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

LATAM Pharmacovigilance (PV) Manager & Mexico Deputy PV Responsible (RPV) is a member of the Global Drug Safety and Pharmacovigilance (DSPV) Department with responsibilities to support Pharmacovigilance in LATAM including the maintenance of the (PV) System in Mexico to ensure the local PV systems are in compliance with regulations and are always audit and inspection ready.
The role will be appointed to fulfill the deputy Responsible Person for PV (RPV) in Mexico and will cover all responsibilities of Mexico RPV when needed.
This role must maintain excellent relationships with all stakeholders, vendors, license partners and other third parties internal and external to Ultragenyx, as well as hands-on PV experience with a proven track record of major accomplishments.

Work Model:

Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.

Responsibilities:

• Be continuously and permanently available to local Regulatory Authorities, specifically in Mexico with COFEPRIS when deputizing for the Mexico RPV in the country.
• Support the establishment and maintenance of Mexico and other local PV systems to ensure Ultragenyx PV practices comply with regulatory requirements and guidelines.
• Contribute to the maintenance of the México Pharmacovigilance System Manual, México Standard Operational Procedures (SOPs), and other LATAM PV procedures.
• Ensure back-up procedures, business continuity, and disaster recovery processes are appropriately implemented, maintained and tested on a routine basis in the country.
• Ensure timely and accurate submissions for México PV related documents to the Regulatory Authorities including but not limited to Individual Case Safety Reports (ICSRs), Aggregate safety reports, responses to safety enquires, and notification to the Regulatory Authority the RPV including deputy.
• Perform and maintain local non-indexed literature searches and Regulatory Intelligence strategy for approved products in LATAM countries, to ensure compliance with local regulations and guidelines.
• Support Mexico Periodic Benefit-Risk Assessment Reports (PBRERs) and Risk Management Plans (RMPs) including risk minimization measures and provide support with the local implementation and oversight of risk minimization measures.
• Support oversight of México PV related activities performed by the local Call Centers / Patient Support Programs (PSP) as well as support AE/SSEs notification training to Ultragenyx employees, partners, vendors, etc. and/or externals providers in México.
• Support with provision of requested documentation and completion of Deviations and Corrective and Preventative Actions (CAPAs) locally.
• Support local internal/external PV audits and inspections.

Requirements:

• Health care professional, resident in Mexico, with a university degree (i.e., third level qualification) in life sciences or allied health fields required (Chemical pharmaceutical).
• Mexico and LATAM Pharmacovigilance experience in Pharmaceutical Industries at minimum 3-5 years (verifiable).
• 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.
• Demonstrated success in initiating and managing partnerships with external vendors and business partners.
• Excellent oral and written communication skills in English (required), Spanish (required).
• Working knowledge of industry standard safety databases (ARGUS), Regulatory databases, and other electronic data capture systems.
• MedDRA trained and working knowledge of MedDRA and WHO Drug dictionaries.
• Willingness to be onsite as needed; some national/international travel may be required; willingness to travel including overnight trips. #LI-CK1 #LI-Hybrid