California Licensed Drug Safety Director

Job Summary

Providing safety science and pharmacovigilance support, the full-time California Licensed Drug Safety Director will lead the production of regulatory documents, support signal detection activities, and perform literature surveillance in a hybrid work environment.

Key responsibilities:

• Develop safety-related regulatory documents including DSURs, PADERs, and PSURs
• Support signal detection activities for clinical programs and marketed products
• Conduct literature surveillance to identify safety issues from published medical literature

Required qualifications:

• Bachelor's degree in life sciences; advanced degree (MD, PharmD, PhD) preferred
• Minimum of 8 years' experience in pharmacovigilance within a pharmaceutical or biotechnology company
• At least 2 years of experience in Safety Surveillance
• Solid understanding of US and international pharmacovigilance regulatory requirements
• Experience in pre- and post-approval pharmacovigilance activities