Global Pharmacovigilance Lead | Safety & Data Insights

Pharming Healthcare, Inc.; New Jersey; Hybrid; USD 105,000 - 135,000; Full time

Benefits offered by this job

Flexible hybrid schedule

Annual bonus

Long-term incentive

Job summary

Pharming Healthcare, Inc. is seeking a Pharmacovigilance Specialist to oversee safety case processing, signal detection, and risk assessment for Pharming products in development and post-authorization.

This hybrid role requires at least two days on-site at our Warren, NJ office, with the flexibility to collaborate across global PV activities and regulatory inquiries. You will maintain PV procedures, ensure regulatory timelines, and support data output for stakeholders while adhering to GCP/ICH

Qualifications

• BS degree in life sciences, pharmacy, or nursing; Masters/PharmD preferred.
• At least three years of pharmacovigilance and drug safety experience.
• Strong knowledge of PV and case processing.
• Familiarity with ARGUS safety databases.

Responsibilities

• Collect reported adverse events (SAEs) for Pharming products in development and post-authorization.
• Check completeness and consistency of reported information.
• Perform case assessment including seriousness and reportability.
• Enter data in PV databases and edit narratives as needed.
• Prepare follow-up queries and obtain missing information from reporters.

Skills

Pharmacovigilance

Drug safety evaluation

GCP/ICH guidelines

Regulatory compliance

Education

BS in life sciences, pharmacy or nursing

Masters or PharmD preferred

Tools

ARGUS

Job description

Pharming Healthcare, Inc. is seeking a Pharmacovigilance Specialist to oversee safety case processing, signal detection, and risk assessment for Pharming products in development and post-authorization.

This hybrid role requires at least two days on-site at our Warren, NJ office, with the flexibility to collaborate across global PV activities and regulatory inquiries. You will maintain PV procedures, ensure regulatory timelines, and support data output for stakeholders while adhering to GCP/ICH