Senior Manager, Pharmacovigilance Document Management Oversight

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description The Senior Manager, 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. Primary duties and responsibilities of the role include the following: Provides leadership to regional aggregate reporting team including training, mentoring, development, and appraisalsAssists in management of departmental budgetsEnsures aggregate reporting processes and procedures are complete and compliant with current regulations globallyInteracts 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 qualityResponsible for global leadership and strategic oversight of aggregate safety reports for investigational and marketed productsCollaborates with Global Safety Teams (GSTs) and with functional areas (Epidemiology, Clinical Operations, Regulatory Affairs, Finance, Safety Statistics, etc.) contributing to aggregate safety reportsManages distribution of assignments and prioritization of tasks within the Pharmacovigilance operations aggregate reporting teamManages 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 appropriateOversee functional specifications of any data requirements for aggregate deliverables from the Global safety database and analytics teamResponsible for maintaining compliance metrics and contributes to implementation of Corrective Action and Preventive Action (CAPA) for non-compliance findingsSupport continuous improvement/quality system initiativesAssist in preparation and support of audits and inspectionsLiaises with Regulatory Affairs to coordinate synchronization of aggregate reportsEstablishes and chairs document working groups comprised of authors and subject matter experts (SMEs) from the project or product teams, as necessary Education and Competencies: Bachelors required. Degree in scientific/medical field or advanced degree preferredMinimum 6+ years pharmaceutical or health care related industry experienceMinimum 5 years of experience in pharmacovigilance with high level of exposure in preparation and submission of periodic aggregate safety reports and risk management plansDemonstrated experience in people management and well-developed skills in teambuilding, motivating and developing peopleExpert knowledge of clinical trial and Pharmacovigilance methodologies including safety profile and risk/benefit analysisExcellent organization skills and ability to prioritize individual and teamwork loadsExpert knowledge of Global regulatory requirementsExperience in vendor management for outsourced activitiesAbility to work in a dynamic environment and manage competing prioritiesUnderstand safety data capture in clinical trials and post marketing settingsGood written and verbal communication skillsAbility to work under strict deadlines and changing priorities with minimal supervisionExcellent negotiation, conflict resolution, decision making, problem solving andcritical thinking skillsExperience with and demonstrated success in working on cross-functional diverse teams requiredAbility to interpret, analyze and clearly present scientific and technical dataScientific / medical writing (including word processing and data presentation packages (i.e., Word, Excel)Ability to thrive in a global matrix environmentExperience with aggregate analysis and writing PSUR's & NOA PeriodicKnowledge of case processing and aggregate reporting requirementsDemonstrated proficiency with computer applications and understanding of safety dataKnowledge of pharmaceutical business, including drug development and regulatory aspectsKnowledge of US, EU and international regulatory/safety regulations andguidelinesFluency in oral and written English LocationsIND - Bengaluru - Research and Development Worker TypeEmployee Worker Sub-TypeRegular Time TypeFull time .