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 focus on Spanish-speaking and Latin American (LATAM) countries. The role includes ensuring compliance with PV requirements, overseeing vendors, conducting PV intelligence assessments, managing local literature processes, reporting, reconciliation, and maintaining alignment with international PV standards.
Major Tasks and Responsibilities
* Conduct PV intelligence assessments for both International PV and aRRM teams, including regulatory intelligence from Spanish-speaking and publishing countries.
* Oversee vendors for South America CT (PVA, Bimonthly report).
* Support local literature processes in LATAM (setup forms, search, monthly review, archival, bi-annual review, reconciliation).
* Maintain expedited reporting rules, RPPV requirements, and LLS requirements, prioritizing Spanish-language countries.
* Track and archive QPPV / RPPV OOO and related documentation.
* Maintain and update QPPV chronology, including contact information, signatures, and notifications to health authorities.
* Host or co-host monthly RPPV meetings.
* Investigate requirements for PV system start-up in assigned countries.
Specific Requirements for the Position
Education : University degree in pharmacy, medicine, or life sciences.
Experience : 5+ years in pharmacovigilance, including clinical trials and product lifecycle management, with familiarity in LATAM environments.
Skills : Strong understanding of PV regulations, reliable, detail-oriented, systematic, able to handle complex issues, multitask, meet deadlines, and eager to learn.
Languages : Fluent in English and Spanish (verbal, written, listening).
Computer Skills : Advanced proficiency in Microsoft Office applications.
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