Associate Director, Program Safety Lead - Job ID: 1908

ascendis pharma

Pharmaceutical Industry

Princeton, NJ - USA

Senior Specialist / Project Manager

Experteer Overview

As Program Safety Lead you drive safety strategy and pharmacovigilance for Ascendis’ endocrinology portfolio. You’ll lead safety activities within a global team, shaping risk management and regulatory submissions. You’ll work cross-functionally to ensure compliant safety profiling, signal evaluation, and medical input for reports and labeling. This role combines strategic leadership with hands-on safety execution in a fast-paced environment, contributing to our mission to deliver therapies for unmet medical needs.

Compensation / Benefits

401(k) plan with company match
Medical, dental, and vision plans
Life and AD&D insurance
Short and long-term disability benefits
Pet Insurance and Legal Insurance
Professional Development

Responsibilities

Define safety strategy for development and marketed products with cross-functional teams
Serve as safety lead for assigned products and oversee patient safety activities
Ensure compliance with global pharmacovigilance regulations, including signal detection and risk management
Develop and maintain safety surveillance and risk management plans
Oversee identification and evaluation of safety signals with timely escalation and resolution
Provide medical and safety input for expedited and aggregate safety reports (SUSARs, PSURs, DSURs, IND Annual Reports)
Contribute to safety sections of labeling, IBs, protocols, consent forms, and regulatory submissions
Collaborate on pharmacovigilance agreements, audits, and regulatory inspections
Monitor industry best practices and update policies/SOPs
Act as a patient safety advisor across Clinical Development, Medical Affairs, Commercial, and PV teams

Key requirements

Eight to ten years of industry pharmacovigilance experience in a fast-paced biopharmaceutical setting
Leadership experience in safety within a matrix organization
Endocrinology Therapeutic Area experience
Clinical medicine experience (preferred)

Strategic thinking with hands-on execution Mentoring and leadership Adaptability and ability to navigate changing priorities Pharmacovigilance leadership Regulatory compliance and safety signal management Safety surveillance and risk management planning

Description

As Program Safety Lead you drive safety strategy and pharmacovigilance for Ascendis’ endocrinology portfolio. You’ll lead safety activities …

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