Pharmacovigilance Medical Writer

Job Summary

Joining a dynamic medical writing team, the full-time Pharmacovigilance Medical Writer will author and review regulatory documents, ensure scientific accuracy, and foster client relationships while working remotely.

Key Responsibilities:

• Author, review, and quality check a variety of regulatory and pharmacovigilance documents, including PSURs, PADERs, and Risk Management Plans
• Ensure documents are scientifically accurate, regulatory compliant, and delivered on time
• Provide guidance and mentoring to junior medical writers while collaborating with cross-functional teams to present safety data effectively

Required Qualifications:

• MD, pharmacy, or Life Science degree (Masters or PhD is desirable)
• Minimum 2 years' experience in Medical Writing or related fields, preferably within a CRO environment
• Strong ability to manage multiple tasks and prioritize workload with attention to detail
• Experience in training and mentoring Associate Medical Writers
• Fluency in English; proficiency in an additional language is a benefit