Pharmacovigilance: Aggregate Reports Specialist

Creative Solutions Services, LLC; Cambridge (MA); Hybrid; USD 96,000 - 124,000; Full time

Benefits offered by this job

Weekly pay

Healthcare benefits

Job summary

Creative Solutions Services, LLC is seeking a Drug Safety Consultant II/Pharmacovigilance Consultant to join the Cambridge, MA team in a hybrid, 12+ month arrangement. You will manage PSURs/DSURs/PADERs and local reports, acting as a safety expert across global processes and cross-functional partners.

You will respond to regulatory questions, support vendor oversight, and drive process improvements to ensure compliant, efficient PV activities.

Qualifications

• Bachelor’s degree in biological or natural sciences required; Advanced degree preferred.
• Minimum 5 years of Pharmacovigilance experience, including aggregate safety report writing.
• Ability to interpret and present scientific data clearly, both verbally and in writing.
• Familiarity with PV regulations and post-marketing safety requirements (case processing, expedited reporting, safety databases).

Responsibilities

• Lead and conduct all aspects of PSURs, DSURs, PADERs, and local reports independently or collaboratively.
• Act as SME on worldwide aggregate reporting safety requirements and represent processes in cross-functional forums.
• Support production scheduling, regulatory oversight, and impact assessments for aggregate reports.
• Assist in authoring responses to safety inquiries from regulators and 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

Cross-functional collaboration

Clinical judgment

Regulatory PV knowledge

Organization

Technical proficiency

Education

Bachelor's degree in biological or natural sciences

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

Tools

Excel

PowerPoint

Word

Business Objects

Job description

Creative Solutions Services, LLC is seeking a Drug Safety Consultant II/Pharmacovigilance Consultant to join the Cambridge, MA team in a hybrid, 12+ month arrangement. You will manage PSURs/DSURs/PADERs and local reports, acting as a safety expert across global processes and cross-functional partners.

You will respond to regulatory questions, support vendor oversight, and drive process improvements to ensure compliant, efficient PV activities.