[Hiring] Senior Manager, Pharmacovigilance @Gan & Lee Pharmaceuticals

Role Description

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.

• Accountable for monitoring, detecting, assessing, and reporting adverse drug reactions (ADRs).
• Ensures effective risk management and regulatory compliance across domestic and international markets.
• Collaborates with clinical operation teams, regulatory authorities, and other stakeholders to support the safety and continued benefit-risk evaluation of products.

Qualifications

• Medical degree.
• 5-10 years of pharmacovigilance or drug safety experience in the pharmaceutical or biotech industry.

Requirements

• 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 for multiple global clinical trials.
• Demonstrated ability to manage multiple tasks simultaneously, prioritize effectively, and identify key issues.
• Outstanding communication skills, with a proven ability to build and maintain strong relationships with regulatory authorities, internal teams, and external partners.

Responsibilities

• Formulate and optimize pharmacovigilance processes and strategy to improve the efficiency and quality of safety assessments and monitoring.
• Oversee the collection, evaluation, analysis, and reporting of ADRs, ensuring compliance with global drug safety monitoring standards.
• Lead drug safety risk assessments, signal detection activities, and the development and implementation of Risk Management Plans (RMPs), promptly identifying and evaluating potential drug safety risks.
• Lead and oversee the management of drug safety data, pharmacovigilance documentation and record, ensuring the accuracy and completeness and confidentiality.
• Participate in pharmacovigilance external audits and regulatory inspections, ensuring compliance with all applicable regulations.
• Lead the preparation and review of drug safety reports (e.g., PSUR, PBRER, DSUR) to ensure compliance with global regulatory standards.
• Assist in the preparation of safety narratives and regulatory submissions.
• Ensure accurate documentation and archiving of pharmacovigilance data in safety databases.
• Provide regular drug safety updates to management, regulatory agencies, and partners, ensuring transparency and compliance in pharmacovigilance activities.
• Collaborate closely with Clinical, Regulatory Affairs, and other departments to ensure timely and effective communication and sharing of drug safety information.
• Provide training to internal teams and external partners on pharmacovigilance processes and requirements.
• Other duties as assigned.