15 sep
|
TFS HealthScience
|
Buenos Aires
15 sep
TFS HealthScience
Buenos Aires
About this role TFS HealthScience is a leading general
mid size Contract Research Organization CRO that partners with
biotechnology and pharmaceutical companies throughout their entire
clinical development journey. Our expertise includes full service
capabilities, resourcing, and Functional Service FSP solutions. The
Pharmacovigilance Consultant LATAM is responsible for providing
local PV support for Expanded Access programs in Argentina and
Chile, ensuring compliance with local regulatory requirements and
timely safety reporting to health authorities. The role includes
oversight of case handling activities and acting as the local PV
contact for regulatory submissions. As part of our SRS FSP team,
you will be dedicated to one sponsor, a global pharmaceutical or
biotechnology company that is an industry leader within its
therapeutic area. Key Responsibilities • Manage local
pharmacovigilance activities for Expanded Access programs in
Argentina and Chile • Ensure timely submission of safety reports to
ANMAT and ISP Chile in line with local regulations • Support case
collection,
medical follow up, compliance tracking, and
reconciliations • Perform or oversee case assessment, review, and
quality control as required • Act as local PV contact and support
regulatory inspections or audits if needed Qualifications •
University degree in Life Sciences, Pharmacy, or related field •
Proven pharmacovigilance experience within Argentina, including
direct interaction with ANMAT • Experience with safety reporting
requirements in Chile is strongly preferred • Previous involvement
in Expanded Access, Compassionate Use, or Named Patient programs •
Fluent in Spanish and English What We Offer We provide
opportunities for personal and professional growth in a rewarding
environment. You will join a team that values collaboration,
quality, and making a difference in the lives of patients. Our core
values of Trust, Quality, Passion, Flexibility, and Sustainability
guide our decisions and sha
📌 Pharmacovigilance Consultant (Buenos Aires)
🏢 TFS HealthScience
📍 Buenos Aires