Senior PV Aggregate Reports Lead (Hybrid/Remote)

Integrated Resources, Inc ( IRI ); Cambridge (MA); Hybrid; USD 66,000 - 110,000; Full time

Job summary

Integrated Resources, Inc. (IRI) in Cambridge, MA is seeking a PV Aggregate Reports Scientist for a hybrid role (2–3 days in the office; remote also considered).

The position is a 12+ month contract with hourly W2 pay between $70 and $80. You will lead and author PSURs, DSURs, PADERs and local reports, act as SME on worldwide aggregate reporting, collaborate with Safety, Clinical Development, Medical Affairs, Regulatory, and external partners, and drive process improvements to ensure compliant,

Qualifications

• Bachelor's degree in biological or natural sciences required.
• Minimum of 5 years of Pharmacovigilance experience including aggregate safety report writing.
• Experience with safety signal management and global PV processes.

Responsibilities

• Lead and conduct all aspects of substantive projects for PSURs, DSURs, PADERs, and local reports.
• Act as an expert on safety requirements and aggregate reporting processes across functions.
• Support worldwide regulatory reviews and provide impact assessments for aggregate reporting.
• Assist in authoring responses to safety inquiries from regulatory authorities with stakeholders.
• Drive process improvements to enhance consistency in aggregate reporting and signal management.
• Maintain procedures and support rollout of new PV processes.

Skills

Data Interpretation & Communication

Cross-Functional Collaboration

Clinical Judgment

Regulatory & PV Knowledge

Organization & Independence

Education

Bachelor's degree in biological or natural sciences

Advanced degree (MSc, PhD, MPH, PharmD, etc.) preferred

Tools

Excel

PowerPoint

Word

Business Objects

Job description

Integrated Resources, Inc. (IRI) in Cambridge, MA is seeking a PV Aggregate Reports Scientist for a hybrid role (2–3 days in the office; remote also considered).

The position is a 12+ month contract with hourly W2 pay between $70 and $80. You will lead and author PSURs, DSURs, PADERs and local reports, act as SME on worldwide aggregate reporting, collaborate with Safety, Clinical Development, Medical Affairs, Regulatory, and external partners, and drive process improvements to ensure compliant,