Associate Director, Pharmacovigilance/ Product Safety

About the role

We're seeking an Associate Director, Pharmacovigilance/ Product Safety for the Drug Safety & Pharmacovigilance team. Reporting to the Executive Director, DSPV Medical Safety, you'll provide medical expertise regarding the safety and risk assessment of Insmed products throughout their lifecycle.

Responsibilities

• Provide medical significance and expectedness assessment of AE/SAE reports and case narratives.
• Compile analysis of similar events (AOSE), individual case comments, RMP analyses, and ad-hoc safety analyses.
• Contribute to safety sections of safety and non-safety documents.
• Author, review, and approve drug-safety related regulatory reports and clinical study documents.
• Interact with drug safety vendors for medical review and safety assessment activities.
• Participate in internal safety review committee meetings.

Requirements

• Masters degree in life sciences, RN, PharmD, or MD with 3-5 years of experience in safety officer or similar role.
• Device experience preferred.
• Expert knowledge of pharmacovigilance regulations and industry standards.
• Strong leadership and communication skills.
• Highly organized with attention to detail.

Qualifications

• Experience managing safety information from clinical development and post-marketing sources.
• Knowledge of MedDRAs and industry-standard pharmacovigilance databases.
• Ability to conduct benefit-risk assessments and prepare regulatory reports.

Skills

• Medical significance and expectedness assessment of adverse event reports.
• Review and approval of safety documentation.
• Communication and collaboration with internal and external stakeholders.
• Ability to manage and analyze large volumes of safety data.

Benefits

Insmed offers comprehensive medical, dental, and vision coverage, mental health support, and a variety of employee benefits including paid time off, fertility and family-forming benefits, caregiver support, flexible work schedules, and more.

Pay

$179,000.00 - $232,500.00 Annual

Schedule

This is a fully remote role with occasional travel for team meetings or events. Travel requirements are minimal, up to 10% annually.