Medical Writer III (Pharmacovigilance)

PrimeVigilance Ltd.; Lisboa; Híbrido; EUR 38.000 - 62.000; Jornada completa

Descripción de la vacante

PrimeVigilance Ltd. in Lisbon, Portugal, is seeking an experienced pharmacovigilance medical writer to join our expanding medical writing team.

You will author, review and quality-check regulatory and pharmacovigilance documents, mentor junior writers, and collaborate with cross-functional teams to interpret safety data for clients. We value accuracy, regulatory compliance, and timely delivery, with opportunities to grow within a global pharmacovigilance specialist.

Formación

• MD, pharmacy or Life Science degree required; advanced degrees desirable.
• Minimum 2 years' experience in Medical Writing and related fields (case processing, signal detection or risk management) ideally within a CRO.
• Ability to manage multiple tasks and prioritize workload.
• Ability to train and mentor Associate Medical Writers.
• Must be a strong team player.
• Fluency in English; an additional language is a benefit.

Responsabilidades

• Author, review, and quality check regulatory and pharmacovigilance documents (PSURs/PBRERs, PADERs, ACOs, DSURs, RMPs).
• Ensure documents are scientifically accurate, regulatory compliant within 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.
• Provide guidance, mentoring, and knowledge sharing to junior medical writers.
• Contribute to process improvements and the continuous enhancement of medical writing quality standards.

Conocimientos

Medical writing experience

Mentoring

Multitasking and prioritization

Team player

English fluency

Educación

MD, pharmacy or Life Science degree

Masters or PhD desirable

Descripción del empleo

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

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.

Qualifications

• 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

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.