About this role
TFS HealthScience is a leading global 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 shape our culture. By aligning on these values we foster collaboration innovation and a shared commitment to excellence. Together we make a difference.
A Bit More About Us
Our journey began over 30 years ago in Sweden in the city of Lund. As a full service global CRO we build solution driven teams working toward a healthier future. Bringing together over 600 professionals TFS delivers tailored clinical research services in more than 50 countries offering flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology Neuroscience Oncology and Ophthalmology.
TFS HealthScience is a global, mid-sized contract research organization (CRO) partnering with biotechnology and pharmaceutical companies across the full clinical development lifecycle. Our expertise spans full-service clinical development, project-based support, strategic resourcing, ... View more