Associate Director - Product Manager, PV Reporting and Surveillance

The Position

Our IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver the services and solutions that help everyone to be more productive and enable innovation.

Our IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver the services and solutions that help everyone to be more productive and enable innovation.

The Information Technology team at our Research & Development Division is looking for Product Manager – PV Reporting and Surveillance. Reporting into the Product Line Lead for Clinical Safety. The position will take a leadership role in the development and implementation of pharmacovigilance strategies, processes, and systems for a pharmaceutical company, ensuring compliance with regulatory requirements and maintaining high-quality standards.

Product managers must possess a broad base of skills and knowledge spanning digital technology, strategy and business planning, user experience design, engineering, and agile/lean development practices. They must possess an entrepreneurial drive to develop new product features while managing stakeholders’ needs and time frames to broker complex relationships that evolve into real solutions. The ultimate success of a product owner hinges on their ability to guide their peers while influencing decision-makers.

• Work with cross-functional teams to develop and implement pharmacovigilance strategies that meet regulatory requirements and ensure patient safety, quality and compliance.
• Manage and prioritize the backlog of changes with value understood.
• Manage the Product Strategy and Roadmap.
• Responsible for managing PV systems, including software systems used for adverse event reporting and signal detection.
• Maintain up-to-date knowledge of global PV regulations and guidelines and ensure that the company’s PV processes and systems comply with these regulations.
• Responsible for ensuring that the company's PV processes and systems follow regulatory requirements, such as the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines.
• Responsible for maintaining high-quality standards for PV processes and systems, and for implementing quality control measures to ensure data accuracy and integrity.
• Collaborate with departments such as clinical, regulatory, and safety to ensure that PV processes are integrated into the overall product development plan.
• Partnering with the business technology partner, managing the implementation of new PVQC systems and changes, and ensuring that project timelines are met.
• Strong Stakeholder management.

• Senior level of experience in Enterprise, Business, Information, Systems & Application or Solution Architecture.
• 5+ years prior experience in a health authority regulated environment.
• Demonstrated ability to effectively partner and communicate with a variety of audiences and stakeholders including executive management, business leaders, IT peers, and colleagues worldwide to navigate across conflicting priorities and balance critical tactical and strategic needs.
• Strong problem-solving skills with a pragmatic approach to addressing challenges.
• Self-directed, self-motivated, driven professional, who with little direction can fill in the gaps as to what is needed, and drive expected results.
• Has the ability to be self-motivated to understand current Patient Safety business needs and current architecture, platforms and systems.
• Experience establishing strategy and execution plans for products…