Senior Pharmacovigilance Associate — Drive Patient Safety Impact

PrimeVigilance; Kraków; On-site; PLN 120,000 - 180,000; Full time

Job summary

PrimeVigilance is seeking a pharmacovigilance specialist to manage ICSR activities within agreed timelines and ensure data protection. You will process safety reports, perform follow-ups, and support SAE/SUSAR handling across client programs.

The role emphasizes collaboration with QA, medical information, and cross-functional teams, with potential progression and protocol reviews as part of the responsibilities.

Qualifications

• Life science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance
• Minimum 1 year of work experience in pharmacovigilance
• Organization skills, including attention to detail and multitasking
• Management skills, including time and issue management
• English - advanced (spoken, written)
• Advanced literacy (MS Office)

Responsibilities

• Performing activities in the scope of ICSR management unit within agreed extent and timeframe
• Processing Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines
• Performing ICSR follow up
• SAE/SUSAR Management (unblinding, clinical trial reconciliation, protocol review, Safety Management Plan review)
• Reconciliation (clinical, partners)
• Personal data protection
• Product Quality Complaint handling and interaction with Quality Assurance
• Medical Information interaction
• MedDRA and WHO coding
• Database Outputs and Reports (including data for monthly reporting to clients)
• Workflow & resource management
• Support of PV processes related to the ICSR management within PrimeVigilance and also to clients
• More senior colleague may perform tasks assigned as per SOP to more junior position
• Performing activities in the scope of ICSR management unit within agreed extent and timeframe
• Supporting the RA & PV Network Department as needed, including acting as the LCPPV (Local Contact Person for Pharmacovigilance) for the specified country and taking on the role of PRLS (Person Responsible for Local Screening) for the designated language, as agreed with the line manager

Skills

English (advanced)

Organization skills

Time management

Multitasking

Attention to detail

MS Office

Education

Life science degree

Pharmacy degree

Nursing degree

Tools

MS Office

Job description

PrimeVigilance is seeking a pharmacovigilance specialist to manage ICSR activities within agreed timelines and ensure data protection. You will process safety reports, perform follow-ups, and support SAE/SUSAR handling across client programs.

The role emphasizes collaboration with QA, medical information, and cross-functional teams, with potential progression and protocol reviews as part of the responsibilities.