Drug Safety Consultant II

Job overview

The Drug Safety Consultant II role is hybrid in Cambridge, MA, with two to three days in the office. Compensation is not specified. The role supports the Safety Surveillance and Aggregate Reports team, which manages processes for worldwide aggregate safety reports. The consultant contributes scientific and regulatory expertise to the preparation and oversight of aggregate reports and related safety responses. By coordinating schedules, reviewing requirements, collaborating with vendors and cross-functional partners, and improving compliant processes, the role supports consistent pharmacovigilance operations.

What you'll do

• Manage and author aggregate reports, including PSURs, DSURs, PADERs, and local reports
• serve as a subject matter expert on safety requirements and company policies
• support the Aggregate Reports Master Schedule and worldwide legislation reviews
• assist with health authority responses
• drive process improvements
• maintain existing procedures and support new process rollouts
• collaborate with vendors, Quality Management, and cross-functional teams.

What we're looking for

Skills & competencies

drug safety consultant ii

cambridge ma

hybrid

mindlance

pharmacovigilance

aggregate safety reports

psur

dsur

pader

safety signal management

regulatory reporting

cross-functional collaboration

Work arrangement

• Weekend coverage required

Why this role

Hybrid schedule requires two to three days in the Cambridge office; requires a bachelor’s degree in biological or natural sciences and at least five years of pharmacovigilance experience, including aggregate safety report writing and safety signal management.

About the employer

Mindlance is hiring for this role. Industry: All Other Professional, Scientific, and Technical Services. Sector: 54.