Senior PV Product Manager - Regulatory & Safety Solutions

Merck; North Wales (Montgomery County); Híbrido; USD 142.000 - 224.000; Tempo integral

Benefícios oferecidos por esta vaga

Medical Insurance

Dental Insurance

401(k) Plan

Paid Holidays

Resumo da vaga

Merck & Co., Inc. seeks a Product Manager – PV Reporting and Surveillance to lead pharmacovigilance strategies, systems, and processes ensuring patient safety and regulatory compliance.

You will collaborate with Clinical, Regulatory, Safety, and IT to align PV with product development and business objectives. The role requires strong governance, data management, and stakeholder management skills in a fast-paced, regulated environment, with hybrid work arrangements and a focus on delivering

Qualificações

• Bachelor’s degree required; 6+ years in data governance, compliance, privacy, risk management, AI governance, or related roles.
• Strong communication skills for technical and non-technical audiences.
• Experience with data governance, data products, digital solutions, and AI-enabled programs.
• Ability to develop policies, standards, SOPs, and governance processes.
• Knowledge of data management practices including quality, metadata, security/privacy, and MDM.
• Ability to identify and manage governance, compliance, privacy, and risk issues.

Responsabilidades

• Partner with cross-functional teams to develop PV strategies meeting regulatory requirements.
• Manage and prioritize product backlog; align business value with objectives.
• Develop and maintain the Product Strategy and Roadmap.
• Oversee PV systems including adverse event reporting and case management tools.
• Ensure compliance with ICH guidelines and global PV regulations.
• Maintain data quality, integrity, and regulatory compliance.
• Collaborate with Clinical, Regulatory, Safety, and other areas to integrate PV into development plans.
• Lead PV/ QC system implementation with Business Technology teams and track milestones.
• Foster strong stakeholder relationships to support decision-making.
• Demonstrate effective communication, influence, and cross-functional collaboration.

Conhecimentos

Strong communication

Stakeholder management

Cross-functional collaboration

Policy development

Data governance

Privacy and compliance

Change leadership

Problem solving

Healthcare regulatory knowledge

Training delivery

Formação

Bachelor’s degree

Ferramentas

Veeva

Descrição da vaga

Merck & Co., Inc. seeks a Product Manager – PV Reporting and Surveillance to lead pharmacovigilance strategies, systems, and processes ensuring patient safety and regulatory compliance.

You will collaborate with Clinical, Regulatory, Safety, and IT to align PV with product development and business objectives. The role requires strong governance, data management, and stakeholder management skills in a fast-paced, regulated environment, with hybrid work arrangements and a focus on delivering