Senior Pharmacovigilance Specialist: Global Patient Safety

PrimeVigilance Ltd.; Kraków; Hybrid; PLN 90,000 - 150,000; Full time

Job summary

PrimeVigilance Ltd. Kraków is seeking an ICSR management professional to execute activities within the ICSR unit, ensuring regulatory compliance and client-specific timelines. You will process ICSR records, perform follow ups, manage SAE/SUSAR activities, and apply MedDRA coding to safety data.

The role supports PV processes for PrimeVigilance and clients, with opportunities to grow. English proficiency and MS Office skills are essential, and a healthcare background is preferred.

Qualifications

• Advanced English (spoken, written) required.
• MS Office proficiency required.
• Strong organizational and multitasking abilities.

Responsibilities

• Process IC SRs from all sources within regulatory timelines.
• Perform ICSR follow up and SAE/SUSAR management.
• Conduct data reconciliation and MedDRA/WHO coding.
• Prepare outputs and reports for monthly client reporting.
• Support PV processes and act as Local Contact Person as needed.

Skills

English (advanced)

MS Office

Organization skills

Time management

Education

Life science degree

Pharmacy/Nursing qualification

Tools

MS Office

Job description

PrimeVigilance Ltd. Kraków is seeking an ICSR management professional to execute activities within the ICSR unit, ensuring regulatory compliance and client-specific timelines. You will process ICSR records, perform follow ups, manage SAE/SUSAR activities, and apply MedDRA coding to safety data.

The role supports PV processes for PrimeVigilance and clients, with opportunities to grow. English proficiency and MS Office skills are essential, and a healthcare background is preferred.