Pharmacovigilance Aggregate Reports Scientist

ProKatchers LLC; Cambridge (MA); On-site; USD 120,000 - 160,000; Full time

Job summary

ProKatchers LLC in Cambridge, MA is seeking a Pharmacovigilance Aggregate Reports Scientist to lead the preparation of PSURs, DSURs, PADERs, and local safety reports for global submissions.

The role requires acting as a PV subject matter expert on global safety regulations, signal management, and aggregate reporting, partnering with cross‑functional teams to ensure timely, compliant submissions.

Qualifications

• Requires a Bachelor’s degree in Life Sciences or related field and 5+ years of pharmacovigilance experience, including aggregate report writing and safety signal management.

Responsibilities

• Lead and manage global aggregate safety reports, including PSURs, DSURs, PADERs, and local safety reports, ensuring timely and compliant delivery.
• Serve as a PV subject matter expert on global safety regulations, signal management, and aggregate reporting requirements.
• Collaborate with Safety, Clinical, Medical Affairs, Regulatory, Quality, and external vendors to support safety reviews and regulatory responses.
• Drive process improvements and maintain consistent, compliant global pharmacovigilance processes and reporting standards.

Skills

Pharmacovigilance experience

Signal management

Aggregate reporting

Education

Bachelor’s degree in Life Sciences or related field

Job description

Job Title: Pharmacovigilance Aggregate Reports Scientist

Location: Cambridge, MA

Duration: 12 months

Job Description:

• Lead and manage global aggregate safety reports, including PSURs, DSURs, PADERs, and local safety reports, ensuring timely and compliant delivery.
• Serve as a PV subject matter expert on global safety regulations, signal management, and aggregate reporting requirements.
• Collaborate with Safety, Clinical, Medical Affairs, Regulatory, Quality, and external vendors to support safety reviews and regulatory responses.
• Drive process improvements and maintain consistent, compliant global pharmacovigilance processes and reporting standards.
• Requires a Bachelor’s degree in Life Sciences or related field and 5+ years of pharmacovigilance experience, including aggregate report writing and safety signal management.