Human Resources Green Card Sponsorship Jobs in Massachusetts

Position Summary

The PV Scientist serves as a product lead for pharmacovigilance activities, supporting the safety profile of assigned products across clinical and post-marketing settings. This role is responsible for signal management, aggregate safety reporting, and day-to-day safety operations, while acting as a subject matter expert on safety data, regulations, and product-specific risk.

Key Responsibilities

Signal Management & Safety Surveillance

- Lead and/or support signal detection, evaluation, and tracking for assigned products
- Analyze and synthesize safety data from multiple sources and author signal evaluation reports
- Facilitate signal review meetings and support Safety Signaling Team discussions
- Conduct ongoing literature review to identify emerging safety information

Regulatory Response & Stakeholder Support

- Draft and coordinate responses to regulatory authority safety inquiries
- Partner cross-functionally to ensure accurate, timely, and aligned communications

Aggregate Safety Reporting

- Lead and/or support the preparation and delivery of aggregate safety reports, including PSURs, DSURs, and line listings
- Contribute to Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS)
- Ensure reports meet regulatory requirements and submission timelines

Clinical Trial Safety Oversight

- Oversee day-to-day safety operations for assigned clinical trials
- Support protocol and informed consent form (ICF) review from a safety perspective
- Contribute to safety management plans and ongoing risk assessment activities

Cross-Functional Collaboration

- Partner with Global Safety Officers, physicians, and cross-functional teams to support safety strategy and risk communication
- Provide input on data analysis, signal detection, and product safety activities

Subject Matter Expertise

- Serve as a safety subject matter expert (SME) on global pharmacovigilance regulations, safety data interpretation, and product risk profiles

Qualifications

- Minimum 7+ years of pharmacovigilance experience, including signal management and aggregate reporting
- Bachelor's degree in life sciences or healthcare field required; advanced degree (PharmD, MPH, PhD, etc.) preferred
- Strong knowledge of MedDRA coding and terminology
- Advanced analytical and problem-solving skills
- Proficiency in Microsoft Excel and data analysis tools
- Ability to manage multiple priorities in a fast-paced environment