01Overview
About the Role
Our client, a globally renowned pharmaceutical company committed to patient safety and the rigorous evaluation of its medicinal products, is seeking a highly experienced Principal Drug Safety Scientist . This critical role is based in Visakhapatnam, Andhra Pradesh, IN , and requires a consistent on-site presence. You will lead pharmacovigilance activities, including the assessment of adverse event data, signal detection, risk management, and regulatory reporting. This position demands a deep understanding of drug safety principles, regulatory requirements, and clinical data interpretation. We are looking for a strategic leader with a strong commitment to patient safety and a proven ability to manage complex drug safety programs.
Key Responsibilities Lead the safety assessment of assigned drug products throughout their lifecycle, from clinical development to post-marketing surveillance. Perform aggregate safety data reviews and identify potential safety signals. Develop and implement risk management plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS). Prepare safety narratives and contribute to periodic safety update reports (PSURs/PBRERs) and other regulatory submissions. Ensure compliance with global pharmacovigilance regulations and guidelines. Collaborate with clinical development, regulatory affairs, medical affairs, and other key stakeholders. Manage and mentor drug safety specialists and contribute to team development. Represent the company in safety-related interactions with regulatory authorities. Contribute to the development and implementation of pharmacovigilance processes and systems. Provide safety expertise and training to internal and external partners. Requirements M.D., Pharm.D., or Ph.D. in a relevant medical or scientific discipline. Minimum of 9 years of progressive experience in drug safety/pharmacovigilance within the pharmaceutical industry. Extensive knowledge of global pharmacovigilance regulations (FDA, EMA, CIOMS). Demonstrated experience in signal detection, safety data analysis, and risk management. Proven ability to author and contribute to safety-related regulatory documents. Strong understanding of clinical trial methodology and interpretation of clinical data. Excellent analytical, critical thinking, and problem-solving skills. Exceptional written and verbal communication skills, with the ability to present complex information clearly. Leadership experience and the ability to manage and mentor a team. Proficiency in safety database systems and pharmacovigilance reporting tools. Benefits Our client offers a highly competitive salary and comprehensive benefits package, including premium health insurance, retirement planning, and generous paid time off. Employees have access to cutting-edge research facilities and resources. Significant opportunities for professional growth, continuing education, and leadership development are provided. This role offers the chance to make a substantial impact on patient safety and contribute to the success of life-saving medicines within a world-leading organization. .
