Pharmacovigilance Medical Writer

Job Summary

Seeking a detail-oriented and motivated Pharmacovigilance Medical Writer, the full-time position offers the opportunity to author and review regulatory documents, ensure compliance, and mentor junior writers 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 scientific accuracy and regulatory compliance of documents while meeting deadlines
• Collaborate with cross-functional teams to analyze and present safety data, acting as a trusted client contact

Required Qualifications:

• MD, pharmacy, or Life Science degree (Masters or PhD preferred)
• Minimum 2 years of experience in Medical Writing or related fields, preferably in a CRO environment
• Proven ability to manage multiple tasks and prioritize effectively
• Experience in training and mentoring Associate Medical Writers
• Fluency in English; additional languages are a plus