Hybrid Senior Pharmacovigilance Lead

KCR Placement; Warszawa; Hybrid; PLN 180,000 - 240,000; Full time

Job summary

ICON Strategic Solutions in Warsaw seeks a Senior Pharmacovigilance Associate to lead pharmacovigilance and drug safety deliverables in a sponsor-dedicated, hybrid role. You will manage adverse event reporting, data interpretation, and regulatory submissions, contributing to patient safety and regulatory compliance.

You will work with cross-functional teams to assess clinical relevance, mentor junior staff, and support audits and inspections, while maintaining PV databases and ensuring data

Qualifications

• Bachelor's degree in a scientific/healthcare field.
• Extensive pharmacovigilance or drug safety experience.
• Strong knowledge of regulations and industry standards.

Responsibilities

• Lead collection, evaluation and processing of adverse event reports per regulatory guidelines.
• Analyze safety data, identify trends and potential signals requiring investigation.
• Prepare and submit PSURs and other regulatory documents with compliance.
• Collaborate with medical/clinical teams on assessing clinical relevance of events.
• Maintain PV databases with accurate documentation and data management standards.
• Provide training and mentorship on PV processes and regulatory requirements.

Skills

Pharmacovigilance

Regulatory knowledge

Data analysis

Adverse event reporting

Mentorship

English fluency

Polish fluency

Communication

Education

Bachelor's degree in life sciences

Tools

PV databases

MS Office

Job description

ICON Strategic Solutions in Warsaw seeks a Senior Pharmacovigilance Associate to lead pharmacovigilance and drug safety deliverables in a sponsor-dedicated, hybrid role. You will manage adverse event reporting, data interpretation, and regulatory submissions, contributing to patient safety and regulatory compliance.

You will work with cross-functional teams to assess clinical relevance, mentor junior staff, and support audits and inspections, while maintaining PV databases and ensuring data