Senior Pharmacovigilance Medical Writer & Mentor

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

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.