Manager, Pharmacovigilance SOPs & Training

Ladders; United States; À distance; USD 100 000 - 120 000; Plein temps

Avantages offerts par ce poste

Health, dental, vision benefits

Retirement plans

Life insurance and disability coverage

Employee assistance programmes

Résumé du poste

Ladders is seeking a Manager, Pharmacovigilance SOPs & Training to lead the development, review, and maintenance of PV quality standards and training materials. You will work with cross-functional teams and external vendors to ensure readiness for inspections and continuous improvement.

The role emphasizes documentation, training, and records accuracy, aligned with CFR/GVP, ICH, and GCP guidelines. Remote-US based candidates only, with a focus on US regulatory expectations.

Qualifications

• Bachelor’s degree in a science or healthcare-related discipline, or equivalent experience.
• Proficiency in written and verbal English.
• Knowledge of CFR/GVP, ICH Guidelines, and GCP.
• Experience preparing and delivering training to various audiences.
• Experience working with learning management systems; Veeva eLMS preferred.
• Strong organizational, time management, and problem-solving skills.

Responsabilités

• Ensure compliance with internal procedures, regulatory requirements, and partner agreements.
• Coordinate development, review, and maintenance of pharmacovigilance quality standard documents.
• Support management of documents through the approval lifecycle within document management systems.
• Train pharmacovigilance and external vendor staff as necessary.
• Maintain accurate and inspection-ready pharmacovigilance training records.
• Support development and maintenance of pharmacovigilance training programs and initiatives.
• Identify quality issues, propose solutions, and escalate as needed.

Connaissances

English proficiency

Training delivery

Organizational skills

Time management

Problem solving

Formation

Bachelor’s degree in science or healthcare

Outils

Veeva eLMS

Description du poste

For our client, we are seeking a Manager, Pharmacovigilance SOPs & Training to join the team of a leader in the Pharmaceuticals & Biotech space.

This role will oversee the development, review, and maintenance of pharmacovigilance quality standards and training materials. The position is focused on ensuring documentation, training, and records are fully aligned with global regulatory expectations and internal procedures. You will partner with cross-functional teams and external vendors to support inspection readiness, compliance, and continuous improvement across pharmacovigilance processes.

Location: Remote - US based candidates only, no visa sponsorship available

Compensation: $100,000 – $120,000 annually

Responsibilities

• Ensure compliance with internal procedures, regulatory requirements, and partner agreements
• Coordinate development, review, and maintenance of pharmacovigilance quality standard documents
• Support management of documents through the approval lifecycle within document management systems
• Train pharmacovigilance and external vendor staff as necessary
• Maintain accurate and inspection-ready pharmacovigilance training records
• Support development and maintenance of pharmacovigilance training programs and initiatives
• Identify quality issues, propose solutions, and escalat...

Qualifications

• Bachelor’s degree in a science or healthcare-related discipline, or equivalent experience
• Proficiency in written and verbal English
• Knowledge of global pharmacovigilance regulations (CFR/GVP), ICH Guidelines, and GCP
• Experience preparing and delivering training to various audiences
• Experience working with learning management systems; Veeva eLMS preferred
• Strong organizational, time management, and problem-solving skills

Benefits

• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Our client is an equal opportunity employer.