Senior Pharmacovigilance Associate

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

Medicine moves forward here. So willyou.

At PrimeVigilance, patient safety is not one part of the job. It is why we exist.

We are a global pharmacovigilance specialist. Our teams help clients navigate complex regulations while keeping patient safety at the center of every decision, from early development through to post-marketing surveillance. Increasingly, the value we create is not only in processing safety data but in interpreting it: spotting the signal that matters early and turning it into insight our clients can act on.

That work takes curious minds, problem-solversand experts who care about getting it right. It also takes a culture worth staying for. Across Europe, North America, South America,Asiaand Australia, we work in an environment built on kindness, flexibility, growth and belonging, where colleagues support one another andgood ideasare heard wherever they come from.

If you want a role with real purpose, globalreachand the chance to keep growing while you help protect patients, you will feel at home here.

Job Description

• 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

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)

Additional Information

When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world.You’lljoin a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.

We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here.

Quality:we hold ourselves to the standard patients deserve.

Integrity and trust:we do the right thing, especially when it is hard.

Drive and passion:we care about theoutcome, becausesomeone is waitingonit.

Agility and responsiveness:we movequickly, becausepatients cannot wait.

Belonging:everyone is welcome, and every voice counts.

Collaborative partnerships:we go further by going together.