Senior Manager, Pharmacovigilance Document Management Oversight

Takeda; Łódź; On-site; PLN 267,000 - 368,000; Full time

Job summary

Takeda in Łódź, Poland is seeking a Senior Manager, Pharmacovigilance Document Management Oversight to lead the regional aggregate reporting team and ensure high-quality safety reports in line with global and local regulations.

You will manage budgets, coordinate cross-functional partners, drive process improvements, and oversee vendor relationships to meet PV requirements and CAPA initiatives. This hybrid role supports a global R&D mission at Takeda.

Qualifications

• Bachelor's degree in scientific/medical field; advanced degree preferred.
• Minimum 7 years in pharmaceutical/healthcare, with PV experience.
• Experience in preparing and submitting aggregate safety reports and risk management plans.

Responsibilities

• Provide leadership to regional aggregate reporting team, including training and mentoring.
• Assist in management of departmental budgets.
• Ensure processes are compliant with current regulations globally.
• Interact effectively in a highly matrix environment.
• Implement and manage structures and tools for high-quality deliverables.
• Provide global leadership and strategic oversight of aggregate safety reports.
• Collaborate with GSTs and functional areas to contribute to aggregate safety reports.
• Manage task assignments and prioritization within PV operations.
• Oversee vendor and partner commitments to meet PV requirements.
• Oversee data requirements and safety database outputs for reports.
• Support CAPA and quality system initiatives.
• Assist in audits and inspections preparation.
• Coordinate with Regulatory Affairs for report synchronization.
• Chair working groups with authors and SMEs as needed.

Skills

Leadership

Budget management

Pharmacovigilance

Cross-functional collaboration

Regulatory knowledge

Project management

Vendor management

Decision making

Communication

Data interpretation

Education

Bachelor's degree in scientific/medical field

Advanced degree preferred

Tools

Word

Excel

Job description

Job Description

About the role:

At Takeda, we are a forward‑looking, world‑class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life‑changing therapies to patients worldwide.

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.

How you will contribute:

• 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
• Oversees 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

Minimum Requirements/Qualifications:

• Bachelors required. Degree in scientific/medical field or advanced degree preferred
• Minimum 7 years pharmaceutical or health care related industry experience
• Minimum 5 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

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient‑focused company that will inspire and empower you to grow through life‑changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as "hybrid" following Takeda's Hybrid and Remote Work policy.

Locations

Lodz, Poland

Base Salary Range

zł267,400.00 - zł367,730.00

For information about our benefits, please click here.

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time