A company is looking for a Remote Associate Director, Clinical Safety Scientist.
Key Responsibilities
Conduct routine safety surveillance and risk management activities
Evaluate safety data to identify potential safety signals and contribute to safety action recommendations
Support regulatory submissions and lead safety deliverables for BLAs, MAAs, and CTDs
Required Qualifications
Bachelor's degree with 6+ years of experience or PharmD / PhD with 3+ years of experience
Experience in clinical development and / or post-marketing
Strong understanding of safety risk management and regulatory environments
Proven ability to collaborate with cross-functional teams
Skilled in conflict management and relationship-building
Clinical Scientist • Fremont, California, United States