What are the responsibilities and job description for the Signal management - Associate Director position at Pharmaceutical Company?
Director, Signal Management & Innovation
📍 Remote / Hybrid | Full-Time
💰 Competitive Salary Bonus Benefits
About the Role
We are seeking an experienced Director, Signal Management & Innovation to join our Global Pharmacovigilance organization. This leadership role will be responsible for driving global signal detection, evaluation, and management strategies while ensuring compliance with worldwide pharmacovigilance regulations.
The ideal candidate will bring strong expertise in drug safety, signal management, risk management, global health authority requirements, and innovative analytics/AI solutions to strengthen patient safety capabilities.
Key Responsibilities
- Lead global signal detection, evaluation, prioritization, and management activities for assigned products.
- Ensure compliance with FDA, EMA, MHRA, ICH, CIOMS, and global pharmacovigilance regulations.
- Partner cross-functionally with Regulatory Affairs, Medical Safety, Epidemiology, Clinical Development, and Data Sciences teams.
- Support preparation and review of aggregate safety reports including PSUR/PBRER, DSUR, PADER.
- Develop and enhance signal management processes, SOPs, governance, and inspection readiness.
- Drive innovation through AI/ML, advanced analytics, dashboards, and automation tools for safety surveillance.
- Present safety findings, trends, and risk-benefit assessments to senior leadership and governance committees.
- Lead vendor oversight for outsourced signal management activities.
- Mentor junior safety scientists and support team development.
- Support regulatory inspections, audits, and health authority responses.
Required Qualifications
- Advanced degree in Life Sciences, Pharmacy, Medicine, Nursing, Public Health, or related field (MD, PharmD, PhD preferred).
- 10 years of Pharmacovigilance / Drug Safety experience.
- Strong expertise in Signal Detection / Signal Management.
- Hands-on experience with global safety regulations and post-marketing surveillance.
- Experience preparing or contributing to PSUR, DSUR, PBRER, PADER reports.
- Strong leadership and cross-functional stakeholder management skills.
- Excellent analytical, communication, and presentation skills.
- Experience with safety databases such as Argus preferred.
- Exposure to AI / Machine Learning / Data Analytics highly preferred.
Preferred Background
Candidates from pharmaceutical, biotech, or CRO environments with global safety operations
experience are strongly encouraged to apply.
Why Join Us
- High-impact leadership role
- Global visibility
- Innovative safety transformation initiatives
- Competitive compensation package
- Opportunity to shape next-generation pharmacovigilance capabilities
Salary : $80 - $115