A growing sponsor organization is hiring a Clinical & Pharmacovigilance (PV) Professional to support innovative Cell & Gene Therapy (CGT) clinical programs. This role is ideal for professionals who combine clinical trial knowledge with pharmacovigilance expertise and are experienced in vendor/CRO oversight within a sponsor environment.
This position plays a critical role in ensuring patient safety, regulatory compliance, and end-to-end safety governance across advanced clinical development programs.
🔬 Role Overview
The Clinical Pharmacovigilance Specialist will act as a bridge between Clinical Operations and Pharmacovigilance, providing strategic safety oversight rather than purely operational PV activities. The role involves hands-on collaboration with Clinical, QA, Regulatory, and external partners, ensuring compliance with global PV regulations throughout the clinical trial lifecycle.
🧬 Key Responsibilities
- Oversee outsourced pharmacovigilance vendors and CROs
- Review, manage, and approve SAEs, SUSARs, and ICSR submissions
- Support preparation and medical review of DSURs and aggregate safety reports
- Provide safety input into clinical protocols, Investigator’s Brochures (IBs), and trial documents
- Collaborate cross-functionally with Clinical Operations, QA, Regulatory Affairs
- Support inspection readiness, audits, and safety governance meetings
- Manage clinical trial safety activities specific to Cell & Gene Therapy, including long-term follow-up requirements
- Ensure compliance with ICH-GCP, ICH E2 guidelines, and global PV regulations
🎯 Eligibility & Qualifications
- Degree in Pharmacy, Life Sciences, or related discipline
- Strong background in Pharmacovigilance and Clinical Trials
- Experience in sponsor oversight or CRO/vendor management
- Solid understanding of clinical safety reporting and global PV regulations
- Exposure to Cell & Gene Therapy, Oncology, Rare Diseases, or Advanced Therapies is highly desirable
- Ability to work effectively in lean, cross-functional sponsor teams
✨ Why Join This Role?
- Work on cutting-edge Cell & Gene Therapy programs
- High-impact strategic pharmacovigilance sponsor role
- Direct involvement in clinical safety decision-making
- Opportunity to grow with a collaborative and innovative sponsor organization
📩 How to Apply
Interested candidates or referrals can share their updated resume via email:
📧 satyaprakash.sharma@microcrispr.com
