Senior Director, Medical Safety

About the role

This position leads the global Medical Safety function, using analytical and report writing skills to support the safety evaluation, benefit/risk assessment, signal detection, aggregate safety report generation and responses to regulatory authority enquiries for Pharming products. This role also contributes to the medical review of individual case safety reports and follow-up questions for Adverse Event reports and provides expert support to internal stakeholders including Clinical Operations, Medical and Regulatory Affairs on matters of patient/subject safety. This role can be based in our Warren, NJ office (with a hybrid work schedule), but we are also open to fully remote candidates who meet the required and preferred qualifications and are able to travel to the NJ office on at least a quarterly basis in addition to the other travel required for the position.

Pharming is a global biotechnology company dedicated to improving the lives of people living with rare diseases. We develop and commercialize innovative therapies for rare and ultra-rare immunological and genetic diseases with significant unmet need, putting patients at the heart of our work and building progress together with caregivers, clinicians, scientists, and partners.

At Pharming, every role helps move rare disease therapies closer to the people who need them. We collaborate across teams, disciplines, and borders because breakthroughs happen when we ask better questions, challenge each other, and turn insight into action. Pharming is a place for builders, problem-solvers, and bold thinkers who move with urgency, take ownership, and stay focused on improving the lives of people living with rare diseases.

Responsibilities

• Responsible for the identification, evaluation, management and escalation of safety risks for Pharming products
• Manages the benefit-risk profile assessment of Pharming’s products
• Identifies, assesses, and monitors signal detection and signal management activities
• Provides responses to enquiries from Competent Authorities (e.g., EMA, MHRA, and