Lead Pharmacovigilance Specialist (Remote)

About the Role Our client, a dynamic and expanding pharmaceutical company with a global reach, is seeking an experienced and detail-oriented Lead Pharmacovigilance Specialist to join their team in a fully remote capacity. This critical role focuses on ensuring the safety of our client's medicinal products by managing and coordinating the collection, detection, assessment, monitoring, and prevention of adverse effects. The Lead Specialist will be responsible for overseeing case processing, regulatory reporting, signal detection, and risk management activities, ensuring compliance with all global regulatory requirements. This position offers a unique opportunity to work from anywhere in South Africa , contributing to patient safety on a global scale. The role requires a proactive approach, strong analytical skills, and the ability to lead and mentor a team in a virtual setting. This is a remote-first opportunity, ideal for a seasoned professional seeking maximum flexibility. Key Responsibilities Oversee the end-to-end pharmacovigilance (PV) process, including adverse event case processing, data entry, and quality control. Ensure timely and accurate submission of safety reports to regulatory authorities worldwide. Lead signal detection activities, including literature review, database analysis, and proactive risk assessment. Develop and implement PV strategies, policies, and standard operating procedures (SOPs). Manage and mentor a team of PV specialists, providing guidance and training on case processing, regulatory requirements, and safety database usage. Conduct periodic safety reviews and contribute to the preparation of aggregate safety reports (e.g., PBRERs, DSURs). Act as a key point of contact for regulatory agencies regarding pharmacovigilance matters. Collaborate with cross-functional teams, including clinical development, medical affairs, and regulatory affairs, to ensure integrated safety management. Manage vendor relationships for outsourced PV activities as needed. Participate in internal and external audits and inspections related to pharmacovigilance. Stay updated on global regulatory intelligence and evolving PV landscape, adapting processes accordingly. Contribute to the development and implementation of risk management plans (RMPs). Requirements A Bachelor's degree in Pharmacy, Medicine, Nursing, Life Sciences, or a related healthcare field. A Master's degree or equivalent professional qualification is preferred. Minimum of 6 years of experience in pharmacovigilance within the pharmaceutical industry, with at least 2 years in a leadership or supervisory role. Comprehensive knowledge of global pharmacovigilance regulations (e.g., FDA, EMA, ICH guidelines) and safety reporting requirements. Proven experience with safety databases (e.g., Argus, ArisG) and case processing. Demonstrated ability in signal detection, risk assessment, and management. Strong analytical and problem-solving skills, with meticulous attention to detail. Excellent leadership, communication, and interpersonal skills, with the ability to manage a remote team effectively. Proficiency in developing and implementing SOPs and quality systems. Ability to work independently, manage multiple priorities, and meet strict deadlines in a remote environment. Must be legally authorized to work in South Africa. Benefits Our client offers a competitive salary package, supplemented by performance-based incentives. Comprehensive health insurance, including medical, dental, and optical coverage, is provided. A robust retirement savings plan and life insurance are also part of the benefits. This fully remote role offers unparalleled flexibility in terms of work location within South Africa . Opportunities for professional growth include specialized training, attendance at virtual industry conferences, and advancement within the pharmacovigilance department. Our client fosters a supportive and collaborative remote culture, ensuring employees feel connected and valued, with potential for future leadership opportunities as the company expands. #J-18808-Ljbffr Placements24