Senior Pharmacovigilance Safety Specialist

Socket.dev; Morrisville (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Senior Safety Specialist to monitor GPS mailbox communications, coordinate case safety reporting, and support aggregate safety reporting. The role requires strong pharmacovigilance knowledge, experience with safety databases like Argus or ArisG, and collaboration across clinical, regulatory, and vendor teams.

Responsibilities include escalating safety issues, contributing to process improvements, and ensuring compliance with global regulations.

Qualifications

• Fluent written and spoken English for safety communications.
• Advanced knowledge of pharmacovigilance processes and global regulations (EU/US/Japan).
• Ability to communicate complex safety issues clearly and concisely.

Responsibilities

• Monitor GPS mailboxes and manage safety communications.
• Review ICSR, listings, tables, and figures for completeness and quality.
• Reconcile serious adverse events across databases and post-market sources.
• Collaborate with clinical, medical, regulatory teams and external vendors for safety information.
• Lead meetings as SME and document minutes and action items.
• Support generation of aggregate safety reports and safety metrics.

Skills

English Fluency

Pharmacovigilance

Safety Databases

Regulatory Knowledge

MS Office

Education

Life Sciences degree

PV certification (preferred)

Tools

ARGUS

ArisG

MedDRA

Job description

Thermo Fisher Scientific is seeking a Senior Safety Specialist to monitor GPS mailbox communications, coordinate case safety reporting, and support aggregate safety reporting. The role requires strong pharmacovigilance knowledge, experience with safety databases like Argus or ArisG, and collaboration across clinical, regulatory, and vendor teams.

Responsibilities include escalating safety issues, contributing to process improvements, and ensuring compliance with global regulations.