Senior Product Lead - Pharmacovigilance & PV Systems

Merck & Co.; Rahway (NJ); Hybrid; USD 120,000 - 160,000; Full time

Benefits offered by this job

Hybrid work model

Pension and health insurance

Paid time off and volunteering

Job summary

Merck & Co. is seeking a Product Manager - PV Reporting and Surveillance to lead pharmacovigilance strategy and systems within our Global Safety framework. You will partner with clinical, regulatory, and IT teams to align PV processes with regulatory requirements and company objectives.

The role requires senior collaboration, backlog prioritization, and hands-on oversight of PV software and data quality, with a focus on safety signal detection and regulatory compliance across regions.

Qualifications

• Extensive pharmacovigilance experience within regulated environments.
• Strong understanding of safety case intake, processing, management and reporting.
• Proven ability to lead product strategy and coordinate with cross-functional teams.

Responsibilities

• Develop and implement pharmacovigilance strategies that meet regulatory requirements.
• Manage and prioritize the backlog of PV changes with clear value.
• Oversee the PV strategy, roadmap, and PV systems including adverse event reporting and signal detection.
• Ensure PV processes comply with global regulatory guidelines (ICH and other standards).
• Collaborate with clinical, regulatory, and safety teams to integrate PV into product development.
• Partner with IT to implement PVQC systems and ensure timelines are met.

Skills

Pharmacovigilance

Patient Safety

Regulatory Compliance

Software Development Life Cycle

Stakeholder Management

Technical Leadership

ITIL Service Delivery

Agile

OKRs

Process Leadership

Tools

Veeva Workbench

Veeva Vault Safety Docs

Veeva Vault Safety

Job description

Merck & Co. is seeking a Product Manager - PV Reporting and Surveillance to lead pharmacovigilance strategy and systems within our Global Safety framework. You will partner with clinical, regulatory, and IT teams to align PV processes with regulatory requirements and company objectives.

The role requires senior collaboration, backlog prioritization, and hands-on oversight of PV software and data quality, with a focus on safety signal detection and regulatory compliance across regions.