Principal, Pharmacovigilance, Device Vigilance

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in the safety monitoring of In Vitro Diagnostic and Software-driven products.

• Oversee the collection, evaluation, reporting, and management of adverse events.

• Ensure adherence to international regulatory standards (e.g., FDA, EU IVDR, Japan).

• Execute case intake, triage, and processing of Individual Case Safety Reports (ICSRs).

• Analyze and assess adverse events linked to diagnostic applications.

• Facilitate medical reviews and causality evaluations of adverse events.

• Aid in aggregate reporting and uphold compliance with global pharmacovigilance regulations.

• Review, triage, and evaluate product complaints concerning genetic and diagnostic testing.

• Prepare and file Medical Device Reports (MDRs) and vigilance reports.

• Collaborate with laboratory operations, bioinformatics, and software development teams.

• Evaluate safety incidents related to software as part of a medical device system.

• Ensure compliance with Standard Operating Procedures (SOPs), Good Vigilance Practice (GVP), and relevant quality systems.

⛳️ Requirements

• Bachelor’s degree in a life science discipline or equivalent qualification.

• An advanced degree in life sciences (MS, PhD, etc.) and/or an MBA is preferred.

• A minimum of 12 years of relevant experience in pharmacovigilance and/or device vigilance.

• Strong understanding of global safety regulations (FDA, EMA, ICH, EU IVDR, Japan).

• Experience with safety databases (e.g., AEMS, Argus, ARISg, Veeva Safety).

• Familiarity with MedDRA coding and the workflows for case processing.

• Knowledge of relevant standards, including ISO 13485 and ISO 14971.

🏝️ Benefits

• Comprehensive medical, dental, vision, life, and disability insurance plans.

• Complimentary testing for employees and their immediate family members.

• Fertility care benefits.

• Leave for pregnancy and baby bonding.

• 401(k) retirement plan benefits.

• Commuter benefits.

• A generous employee referral program.