Senior Manager – Pharmacovigilance

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🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 12%

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Gan & Lee Pharmaceuticals

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1998

🏥 Healthcare

🏭 Manufacturing

💊 Pharmaceuticals

💰 Private Equity Round - Gan & Lee Pharmaceutical on 2015-01

Healthcare • Manufacturing • Pharmaceuticals

Gan & Lee Pharmaceuticals is a China-based global pharmaceutical company focused on developing, manufacturing, and commercializing medicines and medical devices, with particular emphasis on diabetes and oncology treatments. The company conducts international clinical trials, registers and launches products across multiple regions, pursues licensing and partnerships for global rollout of drug candidates (for example, the GLP‑1 receptor agonist bofanglutide/GZR18), and promotes R&D, innovation, and corporate social responsibility.

📋 Description

• Report to the Head of Clinical Development at Gan & Lee Pharmaceuticals USA Corporation or designee • Oversee pharmacovigilance activities to ensure safety and compliance of assets under clinical development • Monitor, detect, assess, and report adverse drug reactions (ADRs) • Ensure effective risk management and regulatory compliance across domestic and international markets • Collaborate with clinical operations teams, regulatory authorities, and other stakeholders to support product safety and benefit-risk evaluation • Formulate and optimize pharmacovigilance processes and strategy • Oversee collection, evaluation, analysis, and reporting of ADRs • Lead drug safety risk assessments, signal detection, and Risk Management Plan (RMP) development and implementation • Manage drug safety data, pharmacovigilance documentation, and records • Participate in external audits and regulatory inspections • Lead preparation and review of PSUR, PBRER, and DSUR drug safety reports • Assist with safety narratives and regulatory submissions • Ensure accurate documentation and archiving of pharmacovigilance data in safety databases • Provide drug safety updates to management, regulatory agencies, and partners • Collaborate with Clinical, Regulatory Affairs, and other departments • Provide training to internal teams and external partners • Perform other duties as assigned

🎯 Requirements

• Medical degree • 5–10 years of pharmacovigilance or drug safety experience in the pharmaceutical or biotech industry • In-depth knowledge of global pharmacovigilance regulations and drug safety practices, including FDA, EMA, and ICH guidelines • Strong analytical and problem-solving capabilities • Meticulous attention to detail and ability to accurately interpret and assess safety data • Proficiency with pharmacovigilance systems and databases, such as Argus and ArisGlobal • Proficiency in data processing software, safety databases, regulatory submission systems, and MedDRA coding • Ability to present and critically discuss safety data in internal and external settings • Experience providing safety inputs for multiple global clinical trials • Ability to manage multiple tasks simultaneously, prioritize effectively, and identify key issues • Outstanding communication skills and ability to build and maintain relationships with regulatory authorities, internal teams, and external partners

🏖️ Benefits

• Remote work arrangement

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