Executive

🚀 We’re Hiring: Clinical & Pharmacovigilance Professional

We are looking for a Clinical + Pharmacovigilance (PV) professional to support our programs in a sponsor environment. This role is ideal for someone who understands clinical trial safety and can provide effective oversight of outsourced PV activities.

🔬 Role Overview

-This position will act as a key link between Clinical Operations and Pharmacovigilance, ensuring patient safety, regulatory compliance, and strong vendor/CRO oversight across CGT clinical studies.

🧬 Key Responsibilities

-Oversee outsourced pharmacovigilance vendors and ensure regulatory compliance

-Review and manage SAEs, SUSARs, and ICSR submissions

-Support preparation and review of DSURs / aggregate safety reports

-Collaborate with Clinical, QA, Regulatory, and CRO teams on safety matters

-Provide safety input into protocols, IBs, and clinical documents

-Support inspection readiness, audits, and safety governance meetings

-Manage clinical trial safety activities specific to Cell & Gene Therapy, including long-term safety follow-up

🎯 Who Should Apply

-Background in Pharmacovigilance + Clinical Trials

-Experience in sponsor oversight or CRO/vendor management

-Strong understanding of clinical safety and global PV regulations

-Exposure to Cell & Gene Therapy, Oncology, Rare Diseases, or Advanced Therapies is a plus

-Comfortable working in lean teams and handling cross-functional responsibilities

✨ Why Join Us?

-Opportunity to work on cutting-edge Cell & Gene Therapy programs

-High-impact role with strategic safety oversight, not just operations

Collaborative, growing sponsor environment

📩 Interested or know someone suitable the please share the updated resume on - satyaprakash.sharma@microcrispr.com

Please reach out or share your profile via direct message or email.

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