Associate Director - Product Manager, PV Reporting and Surveillance

Job Description

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.

The Information Technology team at our Research & Development Divisionis 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 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.

What will you do?

• 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.

Qualifications, Skills & Experience Required

• 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 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.

Nice to have

• Understanding of pharmacovigilance, medical affairs, clinical operations and product quality complaints processes and systems.
• Working Knowledge of Veeva Veeva Workbench and Signal, Vault Safety, Veeva Vault Safety Docs.
• 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.

What we offer

• Exciting work in a great team, global projects, international environment.
• Opportunity to learn and grow professionally within the company globally.
• Hybrid working model, flexible role pattern (e.g., even 80% full-time is possible in justified cases).
• Pension and health insurance contributions.
• Internal reward system plus referral programme.
• 5 weeks annual leave, 5 sick days, 15 days of certified sick leave paid above statutory requirements annually, 40 paid hours annually for volunteering activities, 12 weeks of parental contribution.
• Cafeteria for tax free benefits according to your choice (meal vouchers, sport, culture, health, travel, etc.), Multisport Card.
• Vodafone, Raiffeisen Bank and Foodora discount programmes.
• Up-to-date laptop and iPhone.
• Parking in the garage, showers, refreshments, massage chairs, library, music corner.
• Competitive salary, incentive pay, and many more.

Ready to take up the challenge? Apply now!

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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