Pharmacovigilance Expert at micro1

Pharmacovigilance Expert | $70–80/hr | Worldwide Remote

We are seeking an experienced Pharmacovigilance Expert to join our team on a contract basis. This role is ideal for a detail-oriented drug safety professional with deep expertise in regulatory compliance, aggregate report authoring, and signal management within the pharmaceutical domain.

Key Responsibilities

• Author and review DSURs, PSURs, and PBRERs in accordance with ICH E2F and ICH E2C(R2) guidelines
• Ensure compliance with GVP guidelines and applicable regulatory requirements
• Perform aggregate safety data analysis to support ongoing pharmacovigilance activities
• Conduct signal detection and management, including benefit-risk assessments
• Apply accurate MedDRA coding and perform seriousness, causality, and expectedness assessments
• Execute data reconciliation and maintain high-quality regulatory documentation
• Communicate findings clearly through structured written reports and submissions

Required Skills & Experience

• Proven experience in pharmacovigilance and drug safety
• Strong background in DSUR/PSUR/PBRER authoring and review
• In-depth knowledge of ICH E2F, ICH E2C(R2), and GVP guidelines
• Proficiency in MedDRA coding and safety database management
• Excellent attention to detail and structured written communication skills
• Experience with regulatory documentation and data reconciliation processes

This is a fully remote contract opportunity open to qualified candidates worldwide. Compensation is $70–80/hr depending on experience.