A Manager, Local Pharmacovigilance is a critical leadership role within the pharmaceutical and biotechnology industry, responsible for ensuring drug safety and regulatory compliance at the country or regional level. This profession sits at the intersection of science, regulation, and patient safety, acting as the cornerstone of a company's pharmacovigilance (PV) system within a specific geographic jurisdiction. Professionals in these jobs are tasked with building, maintaining, and overseeing all local PV activities to protect public health and meet stringent national regulatory requirements. Typically, the role involves a broad spectrum of operational and strategic responsibilities. Core duties include the establishment and management of the local pharmacovigilance system, ensuring it integrates seamlessly with the global PV framework. Managers are accountable for the end-to-end handling of Individual Case Safety Reports (ICSRs) originating from their territory, including collection, processing, and regulatory reporting. They maintain key local documents, such as the Pharmacovigilance System Master File (PSMF) annex, and manage local literature screening for adverse event information. A significant part of the job involves regulatory intelligence and submissions, including the local adaptation and submission of Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs), as well as implementing any additional risk minimization measures required by local health authorities. Leadership and quality management are central to the position. Managers often lead a local PV team, providing training, mentorship, and oversight. They ensure all affiliate personnel and third-party vendors are adequately trained on PV obligations. A critical aspect is serving as the primary local contact for pharmacovigilance, hosting and responding to audits and inspections from regulatory agencies. They also engage in local signal detection activities and review promotional and educational materials for safety compliance. The typical skill set and requirements for these jobs are robust. Candidates usually possess a university degree in life sciences, pharmacy, medicine, or a related field, coupled with several years of hands-on pharmacovigilance experience. In-depth knowledge of global ICH guidelines and, crucially, the specific PV legislation of the relevant country/region is mandatory. Strong project management and organizational skills are essential for managing multiple compliance deadlines. Excellent communication and interpersonal abilities are required to liaise effectively with global PV teams, local regulatory affairs, medical departments, and health authorities. Fluency in English and the local language(s) is standard, and proven people management or team leadership capability is a key asset for these senior jobs. For professionals seeking a impactful career at the frontline of drug safety, Manager, Local Pharmacovigilance jobs offer a challenging and rewarding path where scientific expertise directly contributes to patient welfare and regulatory excellence.
