Medical Writer Iii (Pharmacovigilance)

PrimeVigilance Ltd.; Madrid; On-site; EUR 50,000 - 70,000; Full time

Job summary

PrimeVigilance Ltd. is seeking an experienced pharmacovigilance medical writer to join our medical writing team in Madrid. You will deliver high-quality regulatory documents, strengthen client relationships, and help grow the team with your expertise.

The role emphasizes mentoring junior writers, maintaining scientific accuracy, and collaborating with cross-functional teams to present safety data effectively. English fluency is required, and additional languages are a plus.

Qualifications

• 2+ years' experience in Medical Writing, ideally within a CRO environment.
• Ability to manage multiple tasks and prioritize workload with attention to detail.
• Ability to train and mentor Associate Medical Writers.
• Must be a strong team player.
• Fluency in English; additional language is a benefit.

Responsibilities

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

Skills

Medical writing

Regulatory writing

Mentoring

Team player

English fluency

Education

MD / Pharmacy / Life Sciences degree

Job description

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.

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 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, 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.

We look forward to welcoming your application.