Global Pharmacovigilance Leader – Hybrid

Pharming Group; New Jersey; Hybrid; USD 105,000 - 135,000; Full time

Benefits offered by this job

Hybrid work schedule

Competitive benefits package

PTO and holidays

Job summary

Pharming Healthcare, Inc. is seeking a safety evaluation professional to manage case processing, signal detection, and data handling for Pharming products.

This hybrid role requires onsite work at least two days per week in Warren, NJ, with focus on timely reporting to FDA/EMA and regulatory bodies. The candidate will oversee SAE processing, PV database entries, and data visualization to support internal and external safety inquiries while ensuring compliance with PV regulations and company

Qualifications

• Three years of industry experience in pharmacovigilance and drug safety.
• Strong knowledge of pharmacovigilance, case processing and drug safety evaluation.
• Familiarity with safety databases, preferably ARGUS, and PV regulatory requirements.

Responsibilities

• Collect and collate reported (S)AEs for Pharming products in development and post-authorization.
• Assess seriousness and reportability of (S)AEs and maintain data quality.
• Enter data into PV database and edit narratives; prepare follow-up queries.

Skills

Pharmacovigilance

Drug safety

GCP/ICH

ARGUS

Education

Bachelor's in life sciences

Masters/PharmD preferred

Tools

ARGUS

Job description

Pharming Healthcare, Inc. is seeking a safety evaluation professional to manage case processing, signal detection, and data handling for Pharming products.

This hybrid role requires onsite work at least two days per week in Warren, NJ, with focus on timely reporting to FDA/EMA and regulatory bodies. The candidate will oversee SAE processing, PV database entries, and data visualization to support internal and external safety inquiries while ensuring compliance with PV regulations and company