$175,000–$263,000 Per Year
Clinical Assessment, Cross-Functional, Distribution Channel, Maintain Compliance, Medical Dictionary for Regulatory Activities (MedDRA), Mentoring, Patient Safety, Pharmacovigilance, Product Safety, Project/Program Management, Regulations, Regulatory Compliance, Regulatory Submissions, Risk Management, Safety Compliance, Team Lead/Manager, Vendor/Supplier Planning, Vendor/Supplier Relations
The Director, Safety Scientist oversees global patient safety efforts, leading risk management, guiding safety teams, and supporting regulatory activities.
- Responsible for evaluating and resolving safety risks across product portfolios, including regulatory filings and inspections.
- Mentors junior safety scientists, supports cross-functional teams, and leads safety data reviews and signal management.
- Authors safety documents (e.g., PSURs, RMPs) and ensures compliance with global safety regulations.
- Manages risk strategies, vendor relationships, and safety project distribution.
Qualifications: Advanced degree in a health-related field, 7+ years in drug safety/risk management, knowledge of US/EU regulations, and experience in clinical safety assessments.
Preferred skills: Expertise in safety databases, MedDRA, and project management.
Compensation ranges from $175K to $263K, with bonuses, benefits, and opportunities for growth.