About the Role Our client, a global leader in the pharmaceutical sector, is actively seeking a highly experienced Principal Drug Safety Scientist for a fully **remote** position. This critical role involves overseeing and contributing to the pharmacovigilance activities for a portfolio of innovative pharmaceutical products. You will play a key part in ensuring the safety of patients by monitoring drug performance in the real world, identifying potential risks, and contributing to risk management strategies. This **remote-first** opportunity allows you to leverage your extensive expertise from anywhere within the US, providing flexibility while maintaining critical contributions to global health. The successful candidate will operate with a high degree of autonomy, collaborating with international teams to uphold the highest standards of drug safety and regulatory compliance. We are looking for a seasoned professional with a deep understanding of safety surveillance, risk assessment, and regulatory reporting within the pharmaceutical industry. This position is ideal for someone who thrives in an independent work environment and is dedicated to patient well-being. Key Responsibilities Lead the assessment of safety data from various sources, including spontaneous reports, clinical trials, and literature. Develop and maintain safety monitoring plans and risk management strategies for assigned products. Prepare aggregate safety reports (e.g., PBRERs, DSURs) in compliance with global regulatory requirements. Conduct signal detection and evaluation activities, recommending appropriate actions. Collaborate with clinical development, regulatory affairs, and medical affairs teams on safety-related issues. Serve as a key point of contact for regulatory authorities on drug safety matters. Provide safety input for clinical trial protocols, investigator brochures, and informed consent forms. Mentor and guide junior scientists and team members in pharmacovigilance practices. Contribute to the development and implementation of departmental SOPs and quality improvement initiatives. Requirements Advanced degree (MD, PharmD, PhD) in a relevant scientific or medical discipline. Minimum of 8 years of progressive experience in drug safety/pharmacovigilance within the pharmaceutical industry. Extensive knowledge of global pharmacovigilance regulations and guidelines (FDA, EMA, ICH). Proven experience in aggregate safety reporting and signal detection methodologies. Strong analytical skills with the ability to interpret complex safety data. Excellent written and verbal communication skills, with a demonstrated ability to present complex information clearly. Experience working effectively in a remote, cross-functional team environment. Ability to work independently, manage priorities, and meet strict deadlines. Experience with safety databases (e.g., Argus, ArisG) is essential. Leadership experience and the ability to mentor others. Benefits Highly competitive salary with bonus potential. Comprehensive benefits package including health, dental, and vision insurance. Generous paid time off and flexible work arrangements. Retirement savings plan with company contributions. Professional development opportunities and support for continuing education. The flexibility and autonomy of a fully remote position. Direct impact on patient safety and the success of innovative medicines. A supportive and collaborative virtual team culture.