Senior Drug Safety & Pharmacovigilance Specialist - Remote

Theradex Oncology; Princeton (NJ); Remote; USD 80,000 - 115,000; Full time

Benefits offered by this job

Medical, Dental, Vision

Life Insurance

401(k) matching

Job summary

Theradex Oncology is seeking a Senior Pharmacovigilance Professional to lead cross-functional collaboration with internal medical, data, and regulatory teams, as well as external vendors and auditors, ensuring regulatory compliance for SAE management.

The role emphasizes study setup, document development, and rigorous data reconciliation, with responsibilities spanning case processing, reporting, and TMF maintenance. Strong MedDRA/WHO-DD knowledge and ARGUS experience required.

Qualifications

• Bachelor’s degree in a life sciences field or equivalent.
• 3–4 years Drug Safety experience or related.
• SAE and SUSAR experience.

Responsibilities

• Study Setup & Document Development: Prepare SMPs, SAERFs and completion manuals; contribute to safety documents and SOPs.
• Case Management & SAE Processing: Manage SAE reports, enter data in safety database, code events in MedDRA; QC of SAE reports.
• Reporting, Submissions & Stakeholder Notification: Expedite reporting; prepare safety reports for sponsor and regulators; notify team of SAEs.
• Data Reconciliation & Safety Surveillance: Reconcile safety databases and coordinate with data management; periodic review by Medical Monitors; signal detection.
• Trial Master File & Audit Readiness: Maintain PV section of TMF; ensure audit preparedness and support inspections.
• Training & Team Collaboration: Train junior staff; participate in PV team meetings.

Skills

Pharmacovigilance

Regulatory compliance

MedDRA coding

WHO-DD coding

Cross-functional collaboration

English fluency

Education

Bachelor's degree in life sciences

Tools

ARGUS safety database

XML generation

Electronic submissions

Job description

Theradex Oncology is seeking a Senior Pharmacovigilance Professional to lead cross-functional collaboration with internal medical, data, and regulatory teams, as well as external vendors and auditors, ensuring regulatory compliance for SAE management.

The role emphasizes study setup, document development, and rigorous data reconciliation, with responsibilities spanning case processing, reporting, and TMF maintenance. Strong MedDRA/WHO-DD knowledge and ARGUS experience required.