Senior Manager, Global Patient Safety - General Medicine

Location: Dublin, Ireland; hybrid with 3 days per week on site

Salary: €86,800–€141,200 annually

Company

hirify.global is a biotechnology company that discovers, develops, and commercializes medicines for serious diseases.

What you will do

• Develop safety strategies for molecules in clinical development and post-marketing phases within the assigned therapeutic area.
• Conduct signal detection, evaluate identified signals, and author safety evaluation reports.
• Prepare and review safety documents, including DSURs, PSURs, RMPs, and responses to health authority queries.
• Present findings at Signal Management Team meetings and participate in clinical study team meetings.
• Represent Global Patient Safety on cross-functional groups, including safety oversight and independent data monitoring committees.
• Contribute to risk management activities and improve relevant SOPs, work instructions, and supporting documents.

Requirements

• Master's degree, PhD, or PharmD.
• 7+ years of relevant risk management experience in the pharmaceutical or biotechnology industry or a health authority.
• Experience applying FDA, EU, and ICH guidelines and regulations governing pharmacovigilance in clinical trial and post-marketing settings.
• Ability to work with a safety system database for medical case review and simple queries.
• Strong verbal and written communication skills, with the ability to interpret and communicate safety findings.
• Proactive, self-disciplined approach with the ability to prioritize work and meet deliverables.

Culture & Benefits

• Science-driven environment focused on developing medicines for serious diseases.
• Inclusive workplace and equal employment opportunity commitment.
• Comprehensive rewards may include annual bonuses, equity awards, pension or retirement benefits, insurance, paid time off, and family support benefits.
• Reasonable accommodation is available during the recruitment process where required.