Director of Signal Management

Job Summary

A company is looking for a Director, Signal Management - Global Pharmacovigilance - Risk Management.

Key Responsibilities

• Develop, review, evaluate, and maintain signal detection and management processes in compliance with regulations
• Represent the pharmacovigilance department as a subject matter expert in cross-functional teams and ensure compliance with regulations
• Lead training on signal detection processes and oversee signal management activities conducted by vendors

Required Qualifications

• Graduate degree in health sciences, nursing, pharmacy, public health, epidemiology, or a relevant health-related field
• At least 5 years of experience in clinical, pharmacological, or related fields
• In-depth knowledge of clinical trial methodology, pharmacovigilance regulations, and signal detection
• Experience with preparation of aggregate reports and responses to Regulatory Authorities
• Good working knowledge of US and EU drug safety regulations, CIOMS, and ICH guidelines