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