Hybrid Director, Drug Safety bei Evolus

Evolus is a performance beauty company with a customer-centric approach focused on delivering breakthrough products. We are seeking an experienced and driven Director, Drug Safety to join our Safety team reporting to the Chief Medical Officer & Head of R&D. This role will be responsible for overseeing all aspects of safety and pharmacovigilance for Evolus. The lead product is a biologic, PR botulinum toxin A that is now approved and launched. The company has expanded its portfolio to include other aesthetic products and now also has a new range of devices, the Evolysse injectable filler range, approved in the EU and coming soon to the US. If you join our team, you will be working on some of the most exciting opportunities and challenges we face, with a team that values growth, recognition, and camaraderie. 

If you join our team, you will be working on some of the most exciting opportunities and challenges we face, with a team that values growth, recognition, and camaraderie. If you are looking for an opportunity to exhibit your knowledge and technical abilities in a unique environment, then look no further! In this role, you will be challenged to drive the success of Evolus in an effort to build a brand like no other. 

• Interface with various departments internally 
• Oversee safety with regards to and trials ranging from Phase I to III and any post marketing trials such as IIT or Phase IV trials 
• Oversee post-marketing surveillance/vigilance for both drugs and medical devices. 
• Sit as a member of the company’s Joint Safety Committee 
• Be a part of the signal detection assessments and perform risk analysis assessments 
• Ensure compliance with global regulatory bodies regarding safety data reporting, collection, surveillance activities, and documentation will also be important, and this will also be supported by an external resource 
• Implement vigilance-related SOPs and ensure the uniform and timely processing of adverse event data in all assigned development and post-marketing programs 
• Office location – Newport Beach. Hybrid schedule: Monday and Friday remote; Tuesday - Thursday onsite 
• Some travel may be required
• Other duties as assigned 

• 10 years’ experience in drug/biotech safety (safety signal detections, data mining, PV databases), and risk management
• Experience working with full product lifecycle, including post-marketing experience in preparation for global risk management plans
• Aggregate reports and Benefit/Risk Assessments. Problem Solving/Analysis.
• Results Driven Individual
• Extremely proficient in PC and Apple software/apps including Word, Excel, Outlook, PowerPoint, etc.
• Strong verbal and written communication skills. Critical thinking and problem-solving abilities. Excellent decision-making and leadership capabilities. Adaptability reacts to change quickly and calmly 

• MD/DO degree in Health Care is strongly preferred