Director, Global Pharmacovigilance Quality, Standards and Training
DBV Technologies
14 hours ago
Remote friendly (Warren, NJ)
United States
Operations
Responsibilities:
- Verify compliance with SOPs, FDA and ICH guidelines/regulations, and global regulations for safety-related activities.
- Identify and perform QST activities.
- Lead oversight of GPV-related activities performed by third-party vendors/contracted parties.
- Lead global/regional development and revision of drug safety processes, policies, guidelines, SOPs, and training materials.
- Develop and implement the GPV department training program; monitor PV training compliance (including learning tests) and facilitate training classes for GPV and other departments.
- Organize training programs for GPV and non-GPV personnel and/or third-party vendors (needs assessment; curriculum based on job matrix).
- Coordinate training seminars as needed.
- Measure accuracy and timelines for reporting safety information to Health Authorities per internal timelines and partner exchanges.
- Represent GPV QST responsibilities during audits and inspections.
- Investigate deviations; determine root causes; assign CAPAs; oversee CAPA closure with Quality Assurance for issues impacting GPV compliance.
- Develop and maintain inspection readiness program for the GPV organization (with Head of GPV).
Qualifications:
- Minimum B.A./B.S. in life/health sciences or related field.
- 10–15 years pharmaceutical industry experience in Drug Safety, Medical Affairs, Clinical Development, or related.
- Knowledge of clinical and post-marketing safety surveillance.
- Experience with third-party vendor management and Safety Data Exchange Agreements/Pharmacovigilance Agreements.
- Experience with inspection readiness and audits; track record establishing compliant tools/dashboards.
- Experience preparing/delivering drug safety training; strong medical terminology understanding and case processing/reporting knowledge.
- Working knowledge of FDA regulations (e.g., 21 CFR 600, 21 CFR Part 11, 21 CFR Part 4).
- Ability to work independently, manage complex processes, and collaborate effectively.
- Working knowledge of GPV safety databases (e.g., ARISg/LifeSphere); MS Office Suite competency.
Nice to have:
- Experience in immunology or pediatrics/related therapeutic areas.
- Experience supporting postmarketing Organized Data Collection System safety-related programs.
- Verify compliance with SOPs, FDA and ICH guidelines/regulations, and global regulations for safety-related activities.
- Identify and perform QST activities.
- Lead oversight of GPV-related activities performed by third-party vendors/contracted parties.
- Lead global/regional development and revision of drug safety processes, policies, guidelines, SOPs, and training materials.
- Develop and implement the GPV department training program; monitor PV training compliance (including learning tests) and facilitate training classes for GPV and other departments.
- Organize training programs for GPV and non-GPV personnel and/or third-party vendors (needs assessment; curriculum based on job matrix).
- Coordinate training seminars as needed.
- Measure accuracy and timelines for reporting safety information to Health Authorities per internal timelines and partner exchanges.
- Represent GPV QST responsibilities during audits and inspections.
- Investigate deviations; determine root causes; assign CAPAs; oversee CAPA closure with Quality Assurance for issues impacting GPV compliance.
- Develop and maintain inspection readiness program for the GPV organization (with Head of GPV).
Qualifications:
- Minimum B.A./B.S. in life/health sciences or related field.
- 10–15 years pharmaceutical industry experience in Drug Safety, Medical Affairs, Clinical Development, or related.
- Knowledge of clinical and post-marketing safety surveillance.
- Experience with third-party vendor management and Safety Data Exchange Agreements/Pharmacovigilance Agreements.
- Experience with inspection readiness and audits; track record establishing compliant tools/dashboards.
- Experience preparing/delivering drug safety training; strong medical terminology understanding and case processing/reporting knowledge.
- Working knowledge of FDA regulations (e.g., 21 CFR 600, 21 CFR Part 11, 21 CFR Part 4).
- Ability to work independently, manage complex processes, and collaborate effectively.
- Working knowledge of GPV safety databases (e.g., ARISg/LifeSphere); MS Office Suite competency.
Nice to have:
- Experience in immunology or pediatrics/related therapeutic areas.
- Experience supporting postmarketing Organized Data Collection System safety-related programs.