Pharmacovigilance Expert, রিমোট পদ

পদটির নাম Pharmacovigilance Expert, নিয়োগকর্তা micro1। কাজটি মার্কেটিং বিভাগের এবং পুরোপুরি রিমোট। প্রার্থী কোথায় থাকেন তা নিয়ে নিয়োগকর্তার কোনো শর্তই নেই, তাই আপনি যেখানে আছেন সেখান থেকেই আবেদন করতে পারেন।

নিয়োগকর্তা বেতন প্রকাশ করেছেন: $70 - $80 (ঘণ্টাপ্রতি)। কাজের সময় নিয়ে বিজ্ঞাপনে কোনো শর্ত নেই।

এই পদটি একটি স্বয়ংক্রিয় যাচাই পেরিয়ে এসেছে: যেসব বিজ্ঞাপনে বিদেশি ওয়ার্ক পারমিট, ভিসা স্পনসরশিপ, নির্দিষ্ট নাগরিকত্ব বা নির্দিষ্ট কোনো দেশে বসবাস চাওয়া হয়, সেগুলো এই তালিকায় ওঠে না।

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.

Originally posted on Himalayas