Senior Medical Writer Pharmacovigilance & Regulatory Insight

Ergomed; Madrid; On-site; EUR 65,000 - 90,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

Medical writing

Regulatory writing

English fluency

Mentoring

Education

MD/Pharmacy degree

Job description

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.