Local PV Network Manager (LATAM)

iVigee; Santander; Presencial; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

A leading pharmacovigilance services and technology company is seeking a Local PV Network Manager for LATAM. This role involves managing local operations and ensuring compliance with PV regulations across Spanish-speaking regions. Candidates should have a degree in life sciences and extensive pharmacovigilance experience, alongside strong language skills in English and Spanish.

Formación

• 5+ years in pharmacovigilance covering all product lifecycle phases.
• Familiarity with LATAM PV environment.
• Fluent in English and Spanish.

Responsabilidades

• Manage and coordinate local pharmacovigilance operations in Spanish-speaking regions.
• Conduct PV intelligence assessments and manage vendor operations.
• Ensure compliance with local and global PV regulations.

Conocimientos

Attention to detail

Systematic thinking

Multitasking

Willingness to learn

Educación

University degree in pharmacy, medicine, or life sciences

Herramientas

Microsoft Office

Descripción del empleo

iVigee, a leading pharmacovigilance services and technology company focused on creating simple, powerful, and elegant drug safety solutions that span the entire drug safety life cycle, is seeking a new team member for the position of

Local PV Network Manager (LATAM).

The ideal candidate should be based in Spain or another EU country.

We combine years of experience with the latest innovative AI technologies to create the ‘instant pharmacovigilance department’, deployable anywhere, on-demand.

Our teams support clients worldwide with pharmacovigilance, medical, and Argus services from our strategic locations in Europe and the US, across both clinical and post-marketing phases.

Purpose of the Job Position

The Local PV Network Manager will be responsible for managing and coordinating local pharmacovigilance (PV) operations within the assigned region, with a strong focus on Spanish-speaking and Latin American (LATAM) countries. The role is crucial for ensuring compliance with global and local PV requirements, including overseeing vendors, conducting PV intelligence assessments, and managing local literature processes. Additionally, the role includes reporting, reconciliation, and ensuring alignment with international PV standards.

Major Tasks and Responsibilities

• PV intelligence assessments for both International PV and aRRM teams, including reg intel from Spanish-speaking and publishing countries
• Oversee vendor for the South America CT (PVA, Bimonthly report)
• Support on Local literature in LATAM region (Local Literature Set-up Forms, Local Literature Search, Monthly Report Review & Archival, Bi-annual review, Reconciliation)
• Annual maintenance (expedited reporting rules across modalities and operating models, RPPV requirements, LLS requirements) – first priority for Spanish language countries, but applicable globally
• QPPV / RPPV OOO tracking and handover form archival
• QPPV Chronology (internal maintenance and archival of CVs / JDs, record of signature for RPPV network, updates to RPPV chronology including contact info, names, start/end dates, notifications to HAs, etc.)
• Host / Co-host monthly RPPV meetings
• Country start-up investigation of requirements for PV systems – as assigned

Specific Requirements for the Position

Education: University degree in pharmacy, medicine, or life sciences.

Experience: 5+ years in pharmacovigilance, including all product lifecycle phases and clinical trials. Familiarity with LATAM PV environment.

Skills: Strong understanding of local and global PV regulations, reliability, detail-oriented, systematic and structured thinking, ability to handle complex issues, multitasking, meeting deadlines, willingness to learn and accept challenges.

Language Skills: Fluent in English and Spanish (verbal, written, listening).

Computer Skills: Advanced literacy in Microsoft Office applications.