Associate Director - Product Manager, PV Reporting and Surveillance

Scorpion Therapeutics; Rahway (NJ); Hybrid; USD 120,000 - 170,000; Full time

Job summary

Scorpion Therapeutics seeks a Product Manager for PV Reporting and Surveillance within R&D's IT division, leading pharmacovigilance systems and strategies to ensure regulatory compliance and patient safety.

The role involves developing PV strategies, managing PV software including adverse event reporting and signal detection, overseeing system quality and compliance with global PV regulations like ICH guidelines, and collaborating across clinical, regulatory, and safety departments.

Qualifications

• 5+ years in regulated environments.
• Expertise in enterprise systems architecture and stakeholder management.
• Experience with PV regulations (e.g., 21 CFR Part 11) and global safety case management.
• Experience with Veeva Vault and cloud-based architectures preferred.

Responsibilities

• Develop PV strategies and oversee PV software systems including adverse event reporting and signal detection.
• Oversee system quality and regulatory compliance with global PV regulations.
• Collaborate across clinical, regulatory, and safety departments; manage vendor relationships.
• Partner with business technology teams to implement PV systems and ensure timelines and quality.

Skills

Enterprise systems architecture

Stakeholder management

Agile development

PV regulations (21 CFR Part 11)

Tools

Veeva Vault

Cloud-based architectures

Job description

Role:

Product Manager for PV Reporting and Surveillance within R&D's IT division, leading pharmacovigilance systems and strategies to ensure regulatory compliance and patient safety.

Responsibilities:

develop PV strategies, manage PV software systems including adverse event reporting and signal detection, oversee system quality and compliance with global PV regulations like ICH guidelines, and collaborate across clinical, regulatory, and safety departments. Manage vendor relationships and partner with business technology teams to implement PV systems, ensuring project timelines and quality standards are met.

Qualifications:

5+ years in regulated environments, expertise in enterprise systems architecture, stakeholder management, Agile development, and PV regulations (e.g., 21 CFR Part 11). Experience with global safety case management, Veeva Vault, and cloud-based architectures preferred. High-value specifics: focus on pharmacovigilance, global regulatory compliance, R&D within pharmaceuticals, and system management for safety reporting.

Work setup:

hybrid work model, no travel required.