Associate Director, PV Document Management Oversight

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Job Description:

The Associate Director, Pharmacovigilance (PV) Document Management Oversight, is responsible for the development, implementation, and maintenance of robust procedures for the planning, preparation and submission of high-quality aggregate safety reports, in compliance with requisite global and local regulations and requirements.

Accountabilities include

• Provides leadership to regional aggregate reporting team including training, mentoring, development, and appraisals
• Assists in management of departmental budgets
• Ensures aggregate reporting processes and procedures are complete and compliant with current regulations globally
• Interacts and communicates effectively internally and cross-functionally in a highly matrix environment.
• Responsible for the implementation and management of effective structure, procedures, and tools to ensure aggregate report and other functional deliverables are completed with high quality
• Responsible for global leadership and strategic oversight of aggregate safety reports for investigational and marketed products
• Collaborates with Global Safety Teams (GSTs) and with functional areas (Epidemiology, Clinical Operations, Regulatory Affairs, Finance, Safety Statistics, etc.) contributing to aggregate safety reports
• Manages distribution of assignments and prioritization of tasks within the Pharmacovigilance operations aggregate reporting team
• Manages resource planning and ensures adequate support from internal team and vendor team to deliver all scheduled safety reports.
• Manages commitments with license partners to ensure both meet aggregate reporting requirements as per the PV Agreement between companies.
• Provides strategic and financial oversight of Vendor and manages both quality and compliance of assignments, including training and mentoring when appropriate
• Oversee functional specifications of any data requirements for aggregate deliverables from the Global safety database and analytics team
• Responsible for maintaining compliance metrics and contributes to implementation of Corrective Action and Preventive Action (CAPA) for non-compliance findings
• Support continuous improvement/quality system initiatives
• Assist in preparation and support of audits and inspections
• Liaises with Regulatory Affairs to coordinate synchronization of aggregate reports
• Establishes and chairs document working groups comprised of authors and subject matter experts (SMEs) from the project or product teams, as necessary
  
  

Education & Competencies include

• Bachelors required. Degree in scientific/medical field or advanced degree preferred
• Minimum 10 years pharmaceutical or health care related industry experience
• Minimum 7 years of experience in pharmacovigilance with high level of exposure in preparation and submission of periodic aggregate safety reports and risk management plans
• Demonstrated experience in people management and well-developed skills in teambuilding, motivating and developing people
• Expert knowledge of clinical trial and Pharmacovigilance methodologies including safety profile and risk/benefit analysis
• Excellent organization skills and ability to prioritize individual and teamwork loads
• Expert knowledge of Global regulatory requirements
• Experience in vendor management for outsourced activities
• Ability to work in a dynamic environment and manage competing priorities
• Understand safety data capture in clinical trials and post marketing settings
• Good written and verbal communication skills
• Ability to work under strict deadlines and changing priorities with minimal supervision
• Excellent negotiation, conflict resolution, decision making, problem solving and
• critical thinking skills
• Experience with and demonstrated success in working on cross-functional diverse teams required
• Ability to interpret, analyze and clearly present scientific and technical data
• Scientific / medical writing (including word processing and data presentation packages (i.e., Word, Excel)
• Ability to thrive in a global matrix environment
• Experience with aggregate analysis and writing PSUR's & NOA Periodic
• Knowledge of case processing and aggregate reporting requirements
• Demonstrated proficiency with computer applications and understanding of safety data
• Knowledge of pharmaceutical business, including drug development and regulatory aspects
• Knowledge of US, EU and international regulatory/safety regulations and
• guidelines
• Fluency in oral and written English
  
  

Locations:

IND - Bengaluru - Research and Development

Worker Type:

Employee

Worker Sub-Type:

Regular

Time Type:

Full time