Senior Manager, Pharmacovigilance Safety Operations

The Senior Manager, Pharmacovigilance Safety Operations will oversee the timely reporting, processing, and submission of ICSRs from ongoing clinical trials and post-marketing trials, ensuring compliance with regulatory requirements.

Requirements

• Bachelor’s degree in life sciences, pharmacy, or a related field.
• Minimum of 7+ years of experience in safety operations in the biopharmaceutical industry.
• Experience with early and late-stage clinical trials (Phase 3) and post-marketing are highly desirable.
• Experience with device safety reporting and regulatory inspections is a plus.
• Strong knowledge of regulatory requirements (e.g., FDA, ICH guidelines) and industry standards related to drug safety and case processing.
• Demonstrated experience in vendor oversight, submission tracking, and quality control.
• Excellent organizational, analytical, and communication skills.
• Ability to work independently and collaboratively in a fast-paced environment and manage multiple projects simultaneously.
• Proficiency in safety databases and software tools (e.g., Oracle Argus, ARISg, MedDRA).

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Visa Sponsorship