Pharmacovigilance Medical Writer

Job Summary

Seeking a full-time Pharmacovigilance Medical Writer, the successful candidate will author and review regulatory documents, ensure scientific accuracy and compliance, and mentor junior writers while working remotely.

Key Responsibilities:

• Author, review, and quality check a range of regulatory and pharmacovigilance documents, including PSURs, PADERs, ACOs, DSURs, and Risk Management Plans
• Ensure documents are scientifically accurate, regulatory compliant, and delivered within agreed timelines
• Collaborate with cross-functional teams to analyze, interpret, and present safety data effectively

Required Qualifications:

• MD, pharmacy, or Life Science degree (Masters or PhD is desirable)
• Minimum 2 years' experience in Medical Writing and associated fields within a CRO environment
• Ability to effectively train and mentor Associate Medical Writers
• Strong team player with the capacity to manage multiple tasks and prioritize workload
• Fluency in English; an additional language is a benefit