Local Pv Network Manager (Latam)

Sé de los primeros solicitantes.
Solo para miembros registrados
Pontevedra
EUR 50.000 - 75.000
Sé de los primeros solicitantes.
Ayer
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 focus on Spanish-speaking and Latin American (LATAM) countries. The role includes ensuring compliance with PV requirements, overseeing vendors, conducting PV intelligence assessments, and managing literature processes. The role also involves reporting, reconciliation, and maintaining 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 South America CT (PVA, Bimonthly report).
  • Support local literature processes in LATAM, including setup, searches, monthly review, archival, and bi-annual review.
  • Maintain compliance with expedited reporting rules and RPPV requirements, primarily for Spanish-language countries, but globally as well.
  • Track and archive QPPV/RPPV OOO and handover forms.
  • Maintain and update QPPV chronology, including CVs, JDs, contact info, and notification records.
  • Host or co-host monthly RPPV meetings.
  • Investigate PV system requirements for new country start-ups as assigned.

SPECIFIC REQUIREMENTS FOR THE POSITION :

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

Experience: Minimum of 5 years in pharmacovigilance, with experience across the product lifecycle, including clinical trials. Familiarity with LATAM PV environment and regulations is essential.

Reliability and Skills: Detail-oriented, systematic, and able to handle complex issues. Capable of multitasking, eager to learn, and fluent in English and Spanish (verbal and written). Proficient in Microsoft Office applications.