Medical Writer III (Pharmacovigilance)

Ergomed; Madrid; Sur place; EUR 65 000 - 90 000; Plein temps

Résumé du poste

Ergomed Group is seeking an experienced pharmacovigilance medical writer to join our growing medical writing team. You will develop high-quality regulatory documents, strengthen client relationships, and mentor junior writers in a globally distributed pharmacovigilance setting.

The role emphasizes regulatory writing expertise, client-focused delivery, and the ability to grow the medical writing function within a CRO environment. English fluency is required, and additional languages are a plus.

Qualifications

• MD, pharmacy or Life Science degree (Masters or PhD desirable).
• Minimum 2 years' experience in Medical Writing and associated fields (case processing, signal detection or risk management) ideally within a CRO environment.
• Ability to manage multiple and varied tasks and prioritize workload with attention to detail.
• Ability to effectively train and mentor Associate Medical Writers.
• Must be a strong team player.
• Fluency in English; additional language is a benefit.

Responsabilités

• Author, review, and quality check regulatory and pharmacovigilance documents (PSURs, PBRERs, PADERs, ACOs, DSURs, RMPs).
• Ensure documents are scientifically accurate and regulatorily compliant within timelines.
• Collaborate with cross-functional teams to analyse and present safety data.
• Act as a trusted client contact, supporting project delivery and relationships.
• Provide guidance, mentoring, and knowledge sharing to junior writers.
• Contribute to process improvements and quality standards.

Connaissances

Medical writing

Regulatory writing

English fluency

Mentoring

Formation

MD/Pharmacy degree

Description du poste

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.

We are looking for an experienced pharmacovigilance medical writer to join our growing medical writing team.

What We're Looking For:

A highly motivated and detail-oriented medical writer who combines strong regulatory writing expertise with a client-focused mindset and a passion for developing others. You will play a key role in delivering high-quality regulatory documents, strengthening client relationships, and supporting the growth of the wider team. The Medical Writer will be responsible for medical writing including:

Key Responsibilities:

• Author, review, and quality check a range of regulatory and pharmacovigilance documents, including:
  
  
  
  • PSURs/PBRERs
  
  
  • PADERs
  
  
  • ACOs
  
  
  • DSURs
  
  
  • Risk Management Plans (RMPs)
  
  
  
  


• Ensure documents are scientifically accurate, regulatory compliant, and delivered within agreed timelines.


• Collaborate with cross-functional teams to analyse, interpret, and present safety data effectively.


• Act as a trusted point of contact for clients, supporting project delivery and fostering strong working relationships.


• Provide guidance, mentoring, and knowledge sharing to junior medical writers to support their professional growth and development.


• Contribute to process improvements and the continuous enhancement of medical writing quality standards.

• MD, pharmacy or Life Science degree (Masters or PhD is desirable)


• Minimum 2 years' experience in Medical Writingandassociated fields (case processing, signal detection or risk management)ideallywithin a CRO environment


• Ability to manage multiple and varied tasks and prioritize workload with attention to detail


• Ability to effectively train and mentor Associate Medical Writers


• Must be a strong team player


• Fluency in English, an additional language is a benefit

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.