Global Patient Safety Senior Scientist

Global Patient Safety Senior Scientist

Ipsen Pharma

London or Paris

About the Role:

The Global Patient Safety (GPS), Safety Scientist is a key member of the Oncology team. As the Global Patient Safety, Safety Scientist, you support the GPS Therapeutic Area with safety surveillance scientist activities including scientific analyses, case reviews, data reviews & presentations, study team membership, clinical safety

Key Responsibilities:

• Conduct scientific review and interpretation of safety data for aggregate reports, including DSURs, PSURs, CTD modules, and CCDS/labels;
• Support regulatory submissions in line with the overall safety strategy including data analysis for responses to questions, RMP & label proposals;
• Lead and conduct signal detection, risk assessment, evaluation, and (develop) Risk Management Plans;
• Monitor clinical trial safety data throughout development to identify medical concerns and ensure data quality for regulatory compliance;
• Support GPS contributions to Patient Data Collection Systems (e.g., Patient Support Programs, Market Research Programs) and Non-Interventional Studies;
• Clearly present scientific and medical information both verbally and in writing;
• Prepare responses to safety inquiries and manage relationships with external vendors.

Qualifications:

• Bachelor’s degree in biologic or natural science or advanced degree (MSc, PhD, MPH, PharmD, etc.);
• Strong experience in Specialty Care preferably Oncology;
• Extensive industry/pharmacovigilance experience;
• Strong experience in safety reports writing and safety signal management;
• Strong experience in regulatory filing;
• Good knowledge of pharmacovigilance legislation;
• Fluency in English.