Senior Director, PV Science & Aggregate Safety

Alnylam Pharmaceuticals; Philadelphia (Philadelphia County); Hybrid; USD 246,000 - 332,000; Full time

Benefits offered by this job

Total Rewards package

Health and wellness benefits

401(k) with company match

Job summary

Alnylam Pharmaceuticals is seeking a Senior Director of PV Science and Aggregate Reports to lead the PV Science department and a team of PV Scientists, Fellows, and Aggregate report specialists. The role focuses on development and management of safety profiles, and accountability for safety aggregate reports submitted to regulatory authorities, including DSURs, PSURs, and DRMPs.

The position is hybrid, requiring on-site presence 2 days per week in Cambridge or Philadelphia, with collaboration

Qualifications

• Master or doctorate in a medical/healthcare related discipline.
• Minimum 12 years in pharmaceutical industry with at least 8 years in drug safety/pharmacovigilance.
• Minimum 5 years of experience in managing teams.
• Experience in RNAi therapeutics and rare diseases at global level is an advantage.

Responsibilities

• Lead PV Scientists and Fellows and Aggregate report specialists.
• Operationalize PV Science to support risk management systems for investigational and marketed products.
• Collaborate with MSRM leads on signaling, trials, regulatory interactions, and aggregate reports.
• Apply knowledge to problem solving across cross-functional teams.
• Implement and monitor process improvements.
• Oversee PV Scientist participation in Investigator and Site Initiation meetings.
• Provide budget planning and forecasting in partnership with MSRM leadership.
• Develop SOPs and training for Patient Safety and Risk Management.
• Participate in audits, inspections and quality improvements.
• Oversee safety committees and preparation of meeting materials.
• Ensure timely completion of action items and proactive risk management.

Skills

Leadership

PV Science

Aggregate reports

Risk management

Regulatory knowledge

Data analysis

Cross-functional collaboration

Education

Master's or Doctorate in medical/healthcare

Tools

Argus Safety

Signaling tools

PV Analytics

Job description

Alnylam Pharmaceuticals is seeking a Senior Director of PV Science and Aggregate Reports to lead the PV Science department and a team of PV Scientists, Fellows, and Aggregate report specialists. The role focuses on development and management of safety profiles, and accountability for safety aggregate reports submitted to regulatory authorities, including DSURs, PSURs, and DRMPs.

The position is hybrid, requiring on-site presence 2 days per week in Cambridge or Philadelphia, with collaboration