California Licensed Drug Safety Director 3085096 I.Html
Job Description
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
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