About the role

Program Safety Lead at Ascendis Pharma responsible for safety excellence and strategy in a global biopharmaceutical context. Leading pharmacovigilance activities for endocrinology products and collaborating with cross-functional teams.

Responsibilities

Define safety strategy for assigned development and marketed products in collaboration with cross-functional teams
Serve as the safety lead for assigned products, providing strategic recommendations and oversight of patient safety activities
Ensure compliance with global pharmacovigilance regulations, including signal detection, evaluation, and risk management
Develop and maintain safety surveillance and risk management plans for drug development programs
Oversee identification and evaluation of safety signals and ensure timely escalation and resolution
Provide medical and safety input for expedited and aggregate safety reports (e.g., SUSARs, PSURs, DSURs, IND Annual Reports)
Contribute to safety sections of labeling, investigator brochures, protocols, informed consent forms, and regulatory submissions
Collaborate with internal and external stakeholders on pharmacovigilance agreements, audits, and regulatory inspections
Monitor industry best practices and evolving global safety regulations; recommend updates to policies and SOPs
Act as a patient safety advisor across Clinical Development, Medical Affairs, Commercial, and PV teams

You hold a Doctoral degree -- preferably an MD (or equivalent), PhD, PharmD – and are proficient in English at a professional level, both written and spoken.
Minimum of eight years, preferably ten years of industry pharmacovigilance experience in a fast-paced biopharmaceutical company.
Leadership experience within the safety profile of products assigned within a matrix organization
Endocrinology Therapeutic Area experience
Demonstrated skills in clinical medicine with at least 1 year of clinical practice experience is preferred
A passion for advancing innovative therapies that address unmet medical needs for patients struggling with Rare Endocrine Diseases
Comfortable balancing strategic thinking with hands-on execution and mentoring
Demonstrated ability to navigate uncertainty and adapt quickly to changing priorities
Proven track record delivering results in dynamic, fast-paced settings where clarity evolves over time
Ability to travel up to 20% of the time domestically and internationally