Hybrid US Drug Safety Consultant II - Aggregate Reports

TalentBurst, an Inc 5000 company; Cambridge (MA); Hybrid; USD 110,000 - 160,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

Retirement options

Job summary

TalentBurst in Cambridge offers a 12-month Hybrid US_Drug Safety Consultant II role focused on PV aggregate reporting. The candidate will manage PSURs, DSURs, PADERs and local reports, acting as SME for worldwide safety requirements and collaborating with cross-functional teams.

Responsibilities include authoring safety information, coordinating with vendors and QA, driving process improvements, and supporting regulatory responses.

Qualifications

• Bachelor's degree in biological or natural sciences required; Advanced degree preferred.
• 5+ years of Pharmacovigilance experience, including aggregate safety report writing and safety signal management.
• Strong data interpretation and communication skills; ability to present medical data clearly.

Responsibilities

• Serve as SME on worldwide aggregate reporting safety requirements for PV team and cross-functional partners.
• Respond to safety questions and support authoring of medical and scientific safety information.
• Collaborate with vendors and QA to ensure high-quality PV documents.
• Support process improvement and global PV processes.
• Lead and conduct PSURs, DSURs, PADERs, and local reports independently or with others.
• Act as SME on safety requirements and represent processes in cross-functional forums.
• Support Aggregate Reports Master Schedule and annual safety regulatory reviews.
• Assist in authoring regulatory authority responses with PV scientists.
• Drive process optimization to improve consistency in reporting and signal management.
• Maintain existing procedures and support rollout of new PV processes.

Skills

Data interpretation

Cross-functional collaboration

Clinical judgment

Regulatory & PV knowledge

Organization & independence

Technical proficiency

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

TalentBurst in Cambridge offers a 12-month Hybrid US_Drug Safety Consultant II role focused on PV aggregate reporting. The candidate will manage PSURs, DSURs, PADERs and local reports, acting as SME for worldwide safety requirements and collaborating with cross-functional teams.

Responsibilities include authoring safety information, coordinating with vendors and QA, driving process improvements, and supporting regulatory responses.