Associate Director - Product Manager, PV Intake & Processing

Job Description

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 Company's R&D division (our Research & Development Division) is looking for Product Manager – PV Case Intake and Processing. Reporting into Product Line Lead Patient Safety and Quality & Compliance, this position will be responsible for managing 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 stakeholder needs and timeframes 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. 

The following are the key responsibilities of a PV Case Intake & Processing Product Manager:

• Develop and implement PV strategies: Work with cross-functional teams to develop and implement pharmacovigilance strategies that meet regulatory requirements and ensure patient safety, quality and compliance. 

• Oversee PV processes: Responsible for overseeing all PV processes, including adverse event reporting, signal detection, and risk management activities. 

• Manage PV systems: Responsible for managing PV systems, including software systems used for adverse event reporting and signal detection. 

• Maintain PV knowledge: 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. 

• Ensure compliance with regulations: Responsible for ensuring that the company's PV processes and systems are in compliance with regulatory requirements, such as the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines. 

• Maintain quality standards: 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 other departments: Collaborate with departments such as clinical, regulatory, and safety to ensure that PV processes are integrated into the overall product development plan. 

• Communicate PV information to internal and external stakeholders, such as regulatory authorities, health care professionals, and patients. 

• Lead PV projects: Partnering with the business technology partner, managing the implementation new PVQC systems and changes, and ensuring that project timelines are met. 

Education:

• Bachelor’s degree in Computer Science, Engineering, or Life Science

Required Experience and Skills:

• 5+ years prior experience in Enterprise, Business, Information, Systems & Application or Solution Architecture 

• 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 to enable best-in-class IT capabilities.

• Demonstrated partnership working with matrixed IT and client organizations to drive highest value business outcomes aligned to business and future state technology strategies.

• History of developing strong relationships with key vendors to influence vendor’s strategic roadmaps and provide transparency around platform roadmaps.

• Knowledge and experience with Agile Application development, testing