Pharmacovigilance Expert

Micro1; India; A distancia; INR 1.653.000 - 4.822.000; A tiempo parcial

Descripción de la vacante

Cashback24x7 seeks a Pharmacovigilance Expert on a contractor basis to contribute advanced drug safety expertise remotely. You will author and review safety documents and contribute to AI-driven safety tools with clear, high-quality inputs.

Candidates should have 5+ years in PV, DSURs/PSURs/PBRERs experience, proficiency with ICH E2F/E2C and GVP, MedDRA coding, and strong written and verbal communication. Prior QPPV experience is a plus.

Formación

• 5+ years of pharmacovigilance or drug safety experience at sponsor, CRO, or as a consultant.
• Authoring or reviewing DSURs and/or PSURs/PBRERs from start to finish.
• Working fluency with ICH E2F, ICH E2C(R2), and GVP guidelines, including signal management.
• Hands-on MedDRA coding, seriousness and causality assessment, and aggregate safety data analysis.

Responsabilidades

• Author and review evaluation tasks based on DSURs, PSURs/PBRERs, and safety data records.
• Apply expert judgment to assess interval safety findings, signal evaluations, and risk-benefit conclusions.
• Assess template conformity to ICH E2F/E2C requirements and data presentation.
• Reconcile figures and case counts across reports and data sources, documenting discrepancies.
• Deliver structured feedback to inform AI-driven pharmacovigilance tooling.

Conocimientos

Pharmacovigilance experience

DSURs/PSURs/PBRERs experience

ICH E2F/E2C guidelines

MedDRA coding

Safety data analysis

AI-assisted safety review tools

Educación

Advanced life sciences/Pharmacy/Medicine degree

Descripción del empleo

Job Description

Role Title: Pharmacovigilance Expert

Role Type: Contractor

Location: Remote

micro1 is engaging Pharmacovigilance Experts to contribute their advanced drug safety expertise on a key customer project. In this role, you'll apply your expertise to help train next-generation AI systems. Your work will shape how models learn, reason, and perform through high-quality, real-world input. No prior experience in AI is required — your domain knowledge is what matters. This opportunity is ideal for professionals experienced in authoring and reviewing complex safety reports, passionate about data quality, and committed to clear written and verbal communication

Scope of Work

• Author and review evaluation tasks based on DSURs, PSURs/PBRERs, and associated safety data and case-level records.
• Apply expert judgment to assess the accuracy and adequacy of interval safety findings, signal evaluations, and benefit-risk conclusions in alignment with best practices.
• Assess template and structural conformity to ICH E2F and ICH E2C requirements, including proper section content, presentation of cumulative versus interval data, and completeness of appendices.
• Reconcile figures and case counts across report sections and data sources, identifying and documenting discrepancies significant for regulatory review.
• Evaluate safety conclusions in light of new data or events, and provide clear, structured written rationales supporting your determinations.
• Deliver structured feedback to inform the development of AI-driven tools for pharmacovigilance documentation and analysis.

Preferred Qualifications

• 5+ years of pharmacovigilance or drug safety experience at a sponsor, CRO, or as an independent consultant.
• Demonstrated proficiency in authoring or reviewing DSURs and/or PSURs/PBRERs from start to finish.
• Working fluency with ICH E2F, ICH E2C(R2), and GVP guidelines, including signal management and benefit-risk assessment methodology.
• Hands-on experience with MedDRA coding, seriousness and causality assessment, expectedness determination, and aggregate safety data analysis.
• Expertise in reconciling aggregate safety data and identifying inconsistencies with case-level information.
• Advanced degree in life sciences, pharmacy, nursing, or medicine (PharmD, MD, MSc, or equivalent).
• Experience in both development-stage and post-marketing safety reporting, QPPV or deputy QPPV roles, safety committee participation, or AI-assisted safety review tools is a plus.