Senior PV Medical Writer — Regulatory Docs & Mentoring

PrimeVigilance Ltd.; Madrid; On-site; EUR 42,000 - 60,000; Full time

Job summary

PrimeVigilance Ltd. in Madrid seeks an experienced Medical Writer to join our growing pharmacovigilance medical writing team. You will deliver high-quality regulatory documents and support client relationships while mentoring junior writers.

The role requires a medical or life sciences degree, 2+ years in medical writing, and strong regulatory writing expertise. English fluency is essential; additional languages are a plus. This is an on-site position based in Spain with a global reach.

Qualifications

• MD, pharmacy or Life Science degree (Masters or PhD desirable).
• Minimum 2 years' experience in Medical Writing and related fields (case processing, signal detection or risk management) ideally within a CRO environment.
• Ability to manage multiple 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 languages are a benefit.

Responsibilities

• Author, review, and quality check regulatory and pharmacovigilance documents (PSURs, PBRERs, PADERs, ACOs, DSURs, RMPs).
• Ensure documents are scientifically accurate, regulatory compliant and timely.
• Collaborate with cross-functional teams to analyze and present safety data.
• Act as a client contact to support project delivery and relationships.
• Provide guidance and mentoring to junior writers to support growth and quality.

Skills

Regulatory writing

Medical writing

Mentoring junior writers

Client focus

Education

MD or Life Science degree

Masters/PhD desirable

Job description

PrimeVigilance Ltd. in Madrid seeks an experienced Medical Writer to join our growing pharmacovigilance medical writing team. You will deliver high-quality regulatory documents and support client relationships while mentoring junior writers.

The role requires a medical or life sciences degree, 2+ years in medical writing, and strong regulatory writing expertise. English fluency is essential; additional languages are a plus. This is an on-site position based in Spain with a global reach.