Posted over 30 days ago. Roles like this often stay open for a while, so it's still worth applying.
Pharmacovigilance Expert at micro1
posted 3 months agoPharmacovigilance 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.