Senior Pharmacovigilance Associate

Reposted 8 Days Ago
Be an Early Applicant
Zagreb, HRV
Hybrid
Senior level
Biotech • Pharmaceutical
The Role
Manage ICSR processing and follow-up, SAE/SUSAR handling, coding (MedDRA/WHO), reconciliation, product quality complaint handling, database outputs and reporting, and support RA & PV network duties including LCPPV/PRLS responsibilities.
Summary Generated by Built In
Company Description

Medicine moves forward here. So will you. 

 

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-solvers and experts who care about getting it right. It also takes a culture worth staying for. Across Europe, North America, South America, Asia and Australia, we work in an environment built on kindness, flexibility, growth and belonging, where colleagues support one another and good ideas are heard wherever they come from. 

 

If you want a role with real purpose, global reach and the chance to keep growing while you help protect patients, you will feel at home here. We would love to hear from you. 

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’ll join 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 the outcome, because someone is waiting on it. 

  • Agility and responsiveness: we move quickly, because patients cannot wait. 

  • Belonging: everyone is welcome, and every voice counts. 

  • Collaborative partnerships: we go further by going together. 

 

We look forward to welcoming your application. 

Skills Required

  • 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)
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The Company
HQ: London
535 Employees
Year Founded: 1997

What We Do

Founded in 1997, Ergomed is a global provider of high-quality services to the biopharmaceutical industry, spanning all phases of clinical trials, post-approval pharmacovigilance, and medical information. Ergomed’s fast-growing services business includes an industry-leading suite of specialist pharmacovigilance (PV) solutions, integrated under the PrimeVigilance brand, and Ergomed Clinical Research, a complete, global Phase I-IV clinical development and trial management services with a strong heritage in the development of drugs in rare diseases and oncology. • 1,400+ highly qualified professionals • Global full-service CRO • 25+ years of experience • Therapeutic specialization in oncology • Strong expertise in rare disease trials • Robust clinical safety system • Choice of leading drug safety databases Our key services include: • Clinical Research Services • Pharmacovigilance • Medical Information • Regulatory • Medical Writing • Site Management • Study Physician Support • Biostatistics • Patient Study Support

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