Description: 

The Director, Global Pharmacovigilance (GPV) Quality, Standards and Training (QST) will lead all activities supported by the QST division within the GPV department. The Director will assess the quality performance of the GPV Department, including oversight of third-party vendors and contracted parties, develop quality monitoring tools and perform quality assessment of assigned safety reports, safety data reconciliation documents, Key Performance Indicators (KPIs) and other safety documents prepared for and/or affecting compliance of regulatory submission. The Director will facilitate development of standard operating procedures (SOPs) and other process-related documents (e.g. working instructions) for GPV in a regional and global capacity. The incumbent will also develop and implement the GPV department training program, monitor PV-related training compliance, and facilitate training classes for GPV and other departments as needed.

Location: Warren, New Jersey - 3 days on site & 2 days remote

Salary Range: $225k - $275k

Key Responsibilities: 

• Verifies compliance with standard operating procedures, Food and Drug Administration and ICH guidelines and regulations, and global regulations for the management of safety related activities

• Identifies and performs QST activities

• Leads oversight activities for GPV-related activities by third-party vendors

• Leads in the global and regional development and revision of drug safety processes, policies, guidelines, SOPs, and training materials

• Provides applicable training within GPV, other internal functions within DBV and any other external parties or organizations

• Organizes training program for GPV and non-GPV personnel in the company or for third-party vendors, conducting needs assessment, and establishing related training curriculum based on the job matrix

• Coordinates and facilitates training seminars for GPV and other departments within DBV as needed.

• Monitors compliance with all GPV training materials, including learning tests

• Measures accuracy and timelines for reporting safety information to Health Authorities, per internal processing timelines, and exchange with partners

• Represents the GPV department for the QST responsibilities during audits and inspections

• Performs investigations into deviations, determines root causes, assigns appropriate CAPAs, oversees CAPA closure in collaboration with Quality Assurance for issues impacting GPV compliance

• Develops and maintains inspection readiness program for GPV organization in collaboration with Head of GPV

• Performs other departmental duties as assigned
  

Qualifications: 

• Minimum B.A./B.S. in life/health sciences or related field ‘

• Minimum of 10-15 years of pharmaceutical industry experience in Drug Safety, Medical Affairs, Clinical Development, or related

• Knowledge of all aspects and phases of clinical and post-marketing safety surveillance

• Experience with third-party vendor management and Safety Data Exchange Agreements/Pharmacovigilance Agreements

• Experience in inspection readiness and audits

• Track record of establishing compliant processes including tools and dashboards to maintain or improve compliance in drug safety activities

• Experience in preparing and delivering training on drug safety to various audiences

• Understanding of medical terminology, and various aspects of case processing, reporting, medical safety evaluation processes as applicable to QST function

• Working knowledge of Food and Drug Administration Regulations, including but not limited to 21 CFR 600, 21 CFR Part 11, 21 CFR Part 4

• Must be able to work independently, establishing work priorities and direction with minimal input within an evolving GPV Department

• Ability to manage complex processes with a quality-oriented mindset

• Strong interpersonal skills, communication skills (written and oral) and ability to collaborate effectively with other groups

• Working knowledge of GPV safety databases, such as ARISg/LifeSphere

• Competency in MS Office Suite

Nice to Have:

• Prior experience in immunology, pediatrics, or related therapeutic areas

• Experience supporting postmarketing Organized Data Collection System safety-related programs
  

Behavioral skills: 

• Curiosity: Keep on exploring uncharted territories. Always ask “why?” and more importantly “why not?”,

• Courage: Take smart risks, mentor each other to always do better & be accountable for our choices, our opinions, and our actions,

• Collaboration: Teamwork and spirit. Support each other and be equally involved in the achievement of our common goals,

• Credibility: Be transparent, follow through and build trust. Educate ourselves about our unique technology.