Director Drug Safety (1159755)
Company: The Judge Group Agency
- Location: Rockville, United States
- Seniority: Director
- Employment type: Full-time
- Posted: 2 days ago
- Offer language: English
Job description
Location: Rockville, MD
Salary: $180,000.00 USD Annually - $230,000.00 USD Annually
Description: Our client is currently seeking a Director Drug Safety to run day-to-day safety operations across its growing oncology clinical portfolio. This is a hands-on operations role: case processing quality, patient narratives, MedDRA coding, and safety reporting compliance.
This role comes with competitive salary with annual bonus and benefits like 401k match, dental, vision etc.
This Job Will Have The Following Responsibilities
Case management and medical review
- Provide physician medical review of serious adverse event (SAE) and individual case safety report (ICSR) cases from oncology trials, including causality, seriousness, and expectedness assessments.
- Author, review, and approve patient safety narratives for case reports, clinical study reports, and regulatory submissions.
- Perform quality review of draft narratives and case reports prepared by safety vendors and CROs.
- Ensure timely expedited reporting (SUSARs/IND safety reports) to FDA, NMPA, and other health authorities.
Coding and data quality
- Own MedDRA coding conventions and review adverse event coding for accuracy and oncology-appropriate event characterization, including immune-related adverse events.
- Oversee WHODrug coding of concomitant medications.
- Lead SAE reconciliation between the safety database and clinical (EDC) databases.
Safety operations and vendor oversight
- Manage safety vendors and CROs supporting case processing, including KPIs, metrics, and issue escalation.
- Maintain the safety database (e.g., Argus or ARISg) and related workflows.
Qualifications & Requirements:
Required
- MD
- Oncology drug safety experience in industry; solid tumor experience strongly preferred.
- 5+ years of drug safety or pharmacovigilance experience at a pharmaceutical, biotech, or CRO organization, with hands-on case processing and medical review.
- Demonstrated experience writing and reviewing patient safety narratives.
- Strong working knowledge of MedDRA and WHODrug coding.
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Contact: arawat@judge.com
This job and many more are available through The Judge Group. Find us on the web at www.judge.com
