PV Safety & Aggregate Reports Leader

Alnylam Pharmaceuticals; Cambridge (MA); Hybrid; USD 245,500 - 332,100; Full time

Benefits offered by this job

Medical, dental, and vision coverage

Life and disability insurance

401(k) with company match

Paid time off and holidays

Flexible spending accounts

Job summary

Alnylam Pharmaceuticals in Cambridge (hybrid; on-site 2 days/week) seeks a Senior Director of PV Science and Aggregate Reports to lead the PV Science department and the Aggregate reports team, ensuring robust safety profiles across all product lifecycles.

You will partner with the Head of MSRM to drive risk management, signal detection, SOP development, and audits; oversee DSURs, PSURs and line listings; and coordinate with Regulatory Affairs, Medical Writing and Medical Affairs to deliver

Qualifications

• Master or doctorate in a medical/healthcare field or related discipline.
• Strong leadership and matrix collaboration experience.
• Extensive PV knowledge including regulatory requirements.
• Experience with safety operations and aggregate reports.

Responsibilities

• Lead PV Science department and Aggregate report specialists.
• Drive risk management system development and safety signal detection.
• Oversee DSURs, PSURs, and line listings; manage audits and inspections.
• Collaborate with SRM, Regulatory Affairs, Medical Writing, and Medical Affairs.

Skills

Leadership

Cross-functional collaboration

PV safety knowledge

Signal detection

Project management

Communication

Education

Master's or PhD in medical/healthcare

Tools

Argus Safety

Empirica

PV Analytics

Job description

Alnylam Pharmaceuticals in Cambridge (hybrid; on-site 2 days/week) seeks a Senior Director of PV Science and Aggregate Reports to lead the PV Science department and the Aggregate reports team, ensuring robust safety profiles across all product lifecycles.

You will partner with the Head of MSRM to drive risk management, signal detection, SOP development, and audits; oversee DSURs, PSURs and line listings; and coordinate with Regulatory Affairs, Medical Writing and Medical Affairs to deliver