Local Pv Network Manager (Latam)

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:

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 involves ensuring compliance with global and local PV requirements, 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:

• Conduct PV intelligence assessments for both Intl PV and aRRM teams, including regulatory intelligence from Spanish-speaking and publishing countries.
• Oversee vendor activities for the South America Clinical Trial (PVA, Bimonthly report).
• Support local literature processes in the LATAM region, including setup, search, monthly review, archival, bi-annual review, and reconciliation.
• Maintain compliance with expedited reporting rules across modalities and operating models, RPPV requirements, and LLS requirements, prioritizing Spanish language countries but globally as well.
• Track and archive QPPV / RPPV Out of Office (OOO) notifications and handover forms.
• Maintain and archive QPPV chronology, including CVs/JDs, signatures, and contact information.
• Host or co-host monthly RPPV meetings.
• Investigate requirements for PV system start-up in assigned countries.

Specific Requirements:

Education:

• University degree in pharmacy, medicine, or life sciences.

Experience:

• At least 5 years of experience in pharmacovigilance.
• Experience across all product lifecycle phases, including clinical trials.
• Familiarity with LATAM pharmacovigilance environment.
• Strong understanding of local and global PV regulations.
• Reliable, detail-oriented, systematic, and structured thinker.
• Ability to handle complex issues and multitask effectively.
• Willingness to learn and accept challenges.
• Fluent in English and Spanish (verbal, written, listening).
• Proficient in Microsoft Office applications.