Senior Pharmacovigilance Leader

Gan & Lee Pharmaceuticals; New York (NY); On-site; USD 150,000 - 210,000; Full time

Job summary

Gan & Lee Pharmaceuticals USA Corporation is seeking a Senior Manager, Pharmacovigilance to oversee global safety activities, ensure regulatory compliance, and manage ADR monitoring across domestic and international markets.

The role requires 5–10 years of pharmacovigilance experience, strong knowledge of FDA/EMA guidelines, and leadership of cross-functional teams to optimize safety processes and risk management frameworks.

Qualifications

• Medical degree required.
• 5–10 years of pharmacovigilance or drug safety experience.
• Experience across global markets and regulatory standards.

Responsibilities

• Formulate and optimize pharmacovigilance processes and strategy to improve safety assessments and monitoring.
• Oversee collection, evaluation, analysis, and reporting of ADRs with global standards.
• Lead risk assessments, signal detection, and development of Risk Management Plans (RMPs).
• Manage pharmacovigilance data, documentation and confidentiality.
• Participate in pharmacovigilance external audits and regulatory inspections.
• Prepare and review safety reports (PSUR, PBRER, DSUR) for global compliance.
• Assist in safety narratives and regulatory submissions.
• Ensure documentation and archiving of PV data in safety databases.
• Provide regular drug safety updates to management, regulators, and partners.
• Collaborate with Clinical, Regulatory Affairs, and other departments.
• Provide training on PV processes and requirements.
• Other duties as assigned.

Skills

PV regulations

ADR data analysis

PV databases

MedDRA coding

Safety data presentation

Risk management

Regulatory liaison

Cross-functional collaboration

Effective communication

Education

Medical degree

Tools

Argus

ArisGlobal

MedDRA coding software

Regulatory submission systems

Job description

Gan & Lee Pharmaceuticals USA Corporation is seeking a Senior Manager, Pharmacovigilance to oversee global safety activities, ensure regulatory compliance, and manage ADR monitoring across domestic and international markets.

The role requires 5–10 years of pharmacovigilance experience, strong knowledge of FDA/EMA guidelines, and leadership of cross-functional teams to optimize safety processes and risk management frameworks.