Associate Director - Product Manager, PV Intake & Processing

Job Description

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.

Required Experience and Skills:

• 10+ years prior 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 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 and implementation in external hosting and cloud environments.

• Ability for envisioning architectural scheme, information structure and features, functionality, and user-interface designs; leverages current best practices in cloud-based design and development.

• Experience identifying and analyzing business needs and coordinating between product vendors and other stakeholder groups to deliver prompt, efficient and, quality support.

• Demonstrated ability to succeed in a complex and dynamic work environment

• Strong project management, communication, and leadership skills, as well as a thorough understanding of regulatory requirements and quality standards.

• Knowledge of Research and Development within pharmaceuticals life science industry as well as experience with Global Safety Case Intake, Processing, Management and Reporting.

Preferred Capabilities:

• Understanding of pharmacovigilance, medical affairs, clinical operations and product quality complaints processes and systems

• Working Knowledge of some not all of Oracle Argus, Veeva, RxLogix suite of technology products.

• Understanding of regulatory requirements that drive IT delivery, including 21-CFR-Part-11, Annex 11, Good Laboratory and Clinical practices, Computer Systems Validation, and other global regulatory requirements that impact IT systems in the R&D and manufacturing spaces

• Familiarity with risk-based monitoring and other industry applications used for Pharmacovigilance.

Minimum Education Requirements:

Education:

• Bachelor’s degree in computer science, Engineering, or Life Science

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Who we are …

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

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DATA2020

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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Requisition ID:R226848