Requirements: English
Company: iVigee
Region: Oa , Castile and Len
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.
iVigee: Simple. Powerful. Elegant.
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 intel assessments for both Intl PV and aRRM teams - not only, but including reg intel from Spanish speaking/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 Spanish language countries, but global as well
- 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 (contact inform, 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 science
Experience
- 5+ years of experience in the field of pharmacovigilance
- Experience with pharmacovigilance during all product life-cycle, incl. clinical trials
- Familiarity with local pharmacovigilance environment in LATAM countries
Special skills
- Strong understanding of local and global PV regulations.
- Reliability
- Detail oriented
- Systematic and structured way of thinking and working
- Ability to deal with complex issues
- Ability to work on multiple tasks in parallel
- Keeping deadlines
- Willingness to learn and accept challenges
Language skills
- Fluent in English and Spanish (verbal, written and listening)
Computer skills
- Advanced literacy (Microsoft Office applications)