Senior Benefit/Risk Associate

Posted 4 Days Ago
Be an Early Applicant
Hiring Remotely in Zagreb, HRV
In-Office or Remote
Senior level
Biotech • Pharmaceutical
The Role
Performs and supports pharmacovigilance activities, including signal detection setup, line-listing review, complex signal detection reporting, quality control, signal evaluation, action recommendations, regulatory communications, tracking, and cross-functional compliance with procedures and regulations.
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

The Senior Benefit-Risk Associate will be working as part of a project team, performing and supporting contracted pharmacovigilance activities on behalf of PrimeVigilance.  

Key responsibilities: 

  • Participating in signal detection activities including set-up
  • Reviewing line listings required for preparation of signal detection report
  • Drafting complex signal detection reports, including quality control
  • Evaluating and categorizing potential signals
  • Proposing a course of action whenever a potential signal is identified
  • Providing support for preparation of communication with regulatory authorities
  • Record keeping and maintenance of relevant tracking tools
  • Working with other company departments to ensure that signal management is conducted in accordance with relevant PrimeVigilance procedures and regulatory requirements

Qualifications

  • Educational background in Life Sciences or Biomedical fields (Pharmacy degree preferred).
  • Demonstrated previous experience in signal detection is strongly preferred.
  • Strong dedication to contributing to patient safety and a proactive approach to learning.
  • Excellent time and issue management skills, with the ability to delegate, multitask, and maintain strict attention to detail.
  • Strong interpersonal and communication capabilities.
  • Advanced proficiency in English, both verbal and written (minimum B2 level)

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

  • Educational background in Life Sciences or Biomedical fields
  • Pharmacy degree
  • Previous experience in signal detection
  • Dedication to patient safety and proactive learning approach
  • Strong time and issue management skills
  • Ability to delegate and multitask while maintaining strict attention to detail
  • Strong interpersonal and communication capabilities
  • Advanced English proficiency, minimum B2 level, verbal and written
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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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