Senior PV Product Lead, Technical PM

Merck & Co.; North Wales (Montgomery County); Hybrid; USD 142,000 - 224,000; Full time

Job summary

Merck & Co. in Rahway, NJ, seeks a Product Manager - PV Reporting and Surveillance to lead pharmacovigilance strategy, oversee adverse event systems, and ensure regulatory compliance across global safety activities.

You will partner with Clinical, Regulatory, Safety and IT teams, manage backlog and roadmap, and drive governance, data quality, and stakeholder engagement in a fast-paced, regulated environment.

Qualifications

• Bachelor's degree required.
• 6+ years in data governance, compliance, privacy, risk management, or AI governance.
• Strong communication 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 data quality, metadata, security, and master data management.
• Ability to manage governance, compliance, privacy, and risk issues.
• Proven collaboration and influencing across cross-functional teams.
• Ability to drive change and adoption of governance practices.
• Strong writing, organization, and problem-solving skills.
• Ability to work in fast-paced, ambiguous environments.
• Understanding healthcare compliance laws and guidelines.
• Experience delivering training and guidance to broad audiences.

Responsibilities

• Partner with cross-functional teams to develop PV strategies that meet regulatory requirements and ensure patient safety, quality, and compliance.
• Manage and prioritize the product backlog, aligning with organizational objectives.
• Develop, maintain, and execute the Product Strategy and Roadmap.
• Oversee PV systems including software platforms for adverse event reporting and case management.
• Maintain knowledge of global PV regulations and ensure PV processes remain compliant.
• Ensure PV processes adhere to ICH guidelines.
• Maintain high-quality PV processes with data integrity and compliance.
• Collaborate with Clinical, Regulatory, Safety, and other areas to integrate PV into product development.
• Partner with Business Technology to implement PV/QC systems and enhancements.
• Build and maintain stakeholder relationships to support decision-making across functions.
• Demonstrate stakeholder management, communication, and cross-functional collaboration.

Skills

Data Quality Assurance

Management System Development

Pharmaceutical Regulatory Compliance

Pharmacovigilance

Product Management

Stakeholder Relationship Management

Strategic Planning

System Design

Veeva

Education

Bachelor's degree

Master's degree or MBA (preferred)

Job description

Merck & Co. in Rahway, NJ, seeks a Product Manager - PV Reporting and Surveillance to lead pharmacovigilance strategy, oversee adverse event systems, and ensure regulatory compliance across global safety activities.

You will partner with Clinical, Regulatory, Safety and IT teams, manage backlog and roadmap, and drive governance, data quality, and stakeholder engagement in a fast-paced, regulated environment.