Senior Pharmacovigilance Benefit-Risk Specialist

Ergomed; Warszawa; On-site; PLN 120,000 - 180,000; Full time

Job summary

Ergomed Warsaw is seeking a Senior Benefit-Risk Associate to join a project team delivering contracted pharmacovigilance activities for PrimeVigilance. The role focuses on signal detection, risk assessment, and collaboration with regulatory bodies.

You will review line listings, draft signal detection reports, evaluate signals, and maintain tracking tools, while ensuring adherence to PrimeVigilance procedures and global regulations.

Qualifications

• Educational background in Life Sciences or Biomedical fields.
• Demonstrated experience in signal detection is strongly preferred.
• Strong dedication to patient safety and proactive learning.
• Excellent time and issue management with attention to detail.

Responsibilities

• Participating in signal detection activities including set-up.
• Reviewing line listings required for signal detection reports.
• Drafting complex signal detection reports with quality control.
• Evaluating and categorizing potential signals.
• Proposing actions when a potential signal is identified.
• Supporting communication with regulatory authorities.
• Record keeping and tracking tool maintenance.
• Collaborate with other departments to ensure regulatory compliance.

Skills

English proficiency

Time management

Attention to detail

Communication skills

Team collaboration

Education

Life Sciences or Biomedical fields

Pharmacy degree preferred

Job description

Ergomed Warsaw is seeking a Senior Benefit-Risk Associate to join a project team delivering contracted pharmacovigilance activities for PrimeVigilance. The role focuses on signal detection, risk assessment, and collaboration with regulatory bodies.

You will review line listings, draft signal detection reports, evaluate signals, and maintain tracking tools, while ensuring adherence to PrimeVigilance procedures and global regulations.