You will be taken to Takeda India’s own careers page to apply. Job ID 101048516880.
Job description
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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
