Remote Aggregate Reports Specialist - Drug Safety

Proclinical; Cambridge (MA); Remote; USD 90,000 - 130,000; Part time

Job summary

Proclinical seeks an Aggregate Reports Specialist for a contract role in Cambridge, MA with remote work options. You will manage aggregate safety reports and RMP activities across the product lifecycle, coordinating with GPSRM, CROs, and cross-functional teams to ensure timely safety outputs and regulatory compliance.

The role requires 3–5 years in pharma, PV system knowledge (Argus/Arisg), and strong analytical writing skills.

Qualifications

• Minimum 3–5 years in the pharmaceutical industry with drug safety/pharmacovigilance exposure.
• Experience in developing and implementing process improvements in PV
• Ability to work in a matrix environment with cross-functional teams

Responsibilities

• Lead authoring of aggregate safety reports (PSURs, DSURs) with cross-functional partners.
• Oversee PV science line listings from generation to submission.
• Support Risk Management Plan (RMP) activities across the product lifecycle.

Skills

Pharmacovigilance

Cross-functional collaboration

Data analysis

Communication

Project management

Education

MSN/RN

PharmD

Physician Assistant

MD

Tools

Argus

Arisg

Empirica

Spotfire

Job description

Proclinical seeks an Aggregate Reports Specialist for a contract role in Cambridge, MA with remote work options. You will manage aggregate safety reports and RMP activities across the product lifecycle, coordinating with GPSRM, CROs, and cross-functional teams to ensure timely safety outputs and regulatory compliance.

The role requires 3–5 years in pharma, PV system knowledge (Argus/Arisg), and strong analytical writing skills.