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Medical Writer III (Pharmacovigilance)

Role overview

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
  • Must be a strong team player

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

Key facts

Hard skills

Other skills

  • Mentorship
  • Detail Oriented
  • Multitasking
  • Teamwork

About the company

ERGOMED logo

ERGOMED

Contract Research Organizations (CRO)

Ergomed’s fast-growing services business includes an industry-leading suite of specialist pharmacovigilance solutions, integrated under the PrimeVigilance brand and a full range of high-quality clinical research and trial management services under the Ergomed Clinical Research brand. The Ergomed group employs over 1,800 people and operates out of 24 offices around the world, providing its services to researchers and patients in around 100 countries globally. Our Ergomed Clinical Research business was founded in 1997 and provides high-quality clinical research and trial management services globally and across all trial phases (I to IV), specialising in oncology and rare disease trials. We use innovative site-support services which focus on enhancing patient recruitment and engagement, with a strong heritage in Europe and the USA. PrimeVigilance is a global leader in pharmacovigilance and specialised multi-lingual medical information services. Since 2008, the PrimeVigilance business has supported pharmaceutical, biotechnology and genetics companies in managing the global safety of their products, all the way from clinical trial to post-marketing. Our pharmacovigilance services include case processing, signal and risk management, pharmacoepidemiology, audits, training, advisory literature services, medical information and QPPV.

Company details

Company typeLarge
IndustryContract Research Organizations (CRO)
Company size1001 - 5000

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Job description

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

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 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. 

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MR

Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
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