Senior Pharmacovigilance Lead – Remote

Theradex Systems, Inc.; Princeton (NJ); Remote; USD 80,000 - 115,000; Full time

Benefits offered by this job

Medical insurance

Dental & Vision coverage

Tuition reimbursement

Job summary

Theradex Systems, Inc. is seeking a Senior Pharmacovigilance Professional for a remote US role. You will champion cross-functional collaboration with internal medical, data, and regulatory teams, as well as external vendors and auditors, to manage serious adverse events and ensure regulatory compliance.

Responsibilities include study setup, SAE processing, reporting, data reconciliation, TMF maintenance, and training of junior staff. Strong ARGUS, MedDRA, and XML submission skills are essential.

Qualifications

• Bachelor's degree in life sciences or equivalent.
• 3–4 years Drug Safety experience or related.
• SAE and SUSAR experience required.
• ARGUS experience including XML generation and submissions.

Responsibilities

• Study setup: safety plans, SAERFs, completion manuals.
• Case management: SAE processing and data entry in safety database.
• Regulatory submissions: safety reports to authorities and stakeholders.
• Data reconciliation: harmonize safety data with data management.
• TMF & audit readiness: maintain pharmacovigilance sections and support inspections.
• Training: mentor junior staff on safety processes.

Skills

Pharmacovigilance

SUSAR experience

English proficiency

Cross-functional collaboration

Attention to detail

Education

Bachelor's degree in life sciences

Tools

ARGUS safety database

MedDRA

XML generation

Job description

Theradex Systems, Inc. is seeking a Senior Pharmacovigilance Professional for a remote US role. You will champion cross-functional collaboration with internal medical, data, and regulatory teams, as well as external vendors and auditors, to manage serious adverse events and ensure regulatory compliance.

Responsibilities include study setup, SAE processing, reporting, data reconciliation, TMF maintenance, and training of junior staff. Strong ARGUS, MedDRA, and XML submission skills are essential.