Senior Manager/ AD, Pharmacovigilance

Summary The Senior Manager, Pharmacovigilance reports to the Head of Clinical Development at Gan & Lee Pharmaceuticals USA Corporation or designee. This position is responsible for overseeing pharmacovigilance activities to ensure the safety and compliance of assets under clinical development. The Senior Manager, Pharmacovigilance is accountable for monitoring, detecting, assessing, and reporting adverse drug reactions (ADRs), as well as ensuring effective risk management and regulatory compliance across domestic and international markets. This individual will collaborate with clinical operation teams, regulatory authorities, and other stakeholders to support the safety and continued benefit-risk evaluation of products. Education and Credentials Medical degree. Experience 5-10 years of pharmacovigilance or drug safety experience in the pharmaceutical or biotech industry. Skills In-depth knowledge of global pharmacovigilance regulations and drug safety practices, including FDA, EMA, and ICH guidelines. Strong analytical and problem-solving capabilities, with meticulous attention to detail and the ability to accurately interpret and assess safety data. Proficiency with pharmacovigilance systems and databases (e.g., Argus, ArisGlobal). Proficiency in data processing software, safety databases, regulatory submission systems, and MedDRA coding. Skilled in presenting and critically discussing safety data in both internal and external settings. Experience providing safety inputs