Global Pharmacovigilance Manager – Safety Lead

Pharming Group N.V.; United States; Hybrid; USD 105,000 - 135,000; Full time

Benefits offered by this job

Flexible hybrid work schedule

Annual target bonus

401(k) with company match

Paid Time Off

Health and wellness program

Job summary

Pharming Group N.V. is seeking a Pharmacovigilance professional to oversee safety evaluation and case processing for its products in development and post-authorization. You will manage expedited reporting to FDA/EMA and other authorities, perform data retrieval, and respond to safety inquiries.

In-depth PV knowledge and ARGUS experience are essential. The role emphasizes compliance with PV regulations, data integrity, and timely communication with reporters and authorities, with a flexible

Qualifications

• BS in life sciences, pharmacy, or nursing; advanced degree preferred.
• 3+ years of industry experience in pharmacovigilance and drug safety.
• Strong knowledge of PV practices and regulatory requirements.
• Experience with ARGUS PV database highly preferred.
• Good understanding of GCP/ICH guidelines.

Responsibilities

• Collect and collate reported (S)AEs for Pharming products.
• Assess seriousness and reportability of events.
• Enter data into PV database and edit narratives.
• Prepare follow-up queries and obtain missing information.
• Expedite submission of individual case safety reports to authorities within required timelines.
• Develop data outputs and visualizations for internal stakeholders.

Skills

PV knowledge

Case processing

Data entry

Regulatory awareness

Education

B.S. life sciences or related

Masters or PharmD preferred

Tools

ARGUS PV database

Job description

Pharming Group N.V. is seeking a Pharmacovigilance professional to oversee safety evaluation and case processing for its products in development and post-authorization. You will manage expedited reporting to FDA/EMA and other authorities, perform data retrieval, and respond to safety inquiries.

In-depth PV knowledge and ARGUS experience are essential. The role emphasizes compliance with PV regulations, data integrity, and timely communication with reporters and authorities, with a flexible