Drug Safety Scientist

1w1 week ago

Idorsia

Allschwil, CH · Full-time · CHF 120,000 – CHF 160,000

About this role

Headquartered near Basel, Switzerland – a European biotech hub – Idorsia is looking for a motivated Safety Scientist to support the benefit–risk evaluation of its products and contribute to patient safety throughout the product lifecycle. You will lead signal management activities, contribute to planning and preparation of periodic safety reports such as DSUR and PBRER, and support the Drug Safety Physician in safety data analysis.

In daily work, act as the safety signal tracking and management lead to ensure new signals are documented and actions completed timely. Monitor PRAC meeting documents and relevant sources for safety information on Idorsia products, same class, or competitors. Provide expertise on global pharmacovigilance regulations and guidelines.

Coordinate schedules and responsibilities for periodic safety reports, working closely with Drug Regulatory Affairs, Clinical Pharmacology, Clinical Science, and Global Medical Affairs. Act as lead author in medical writing of reports alongside the Drug Safety Physician. Participate in literature reviews and ensure timely regulatory submissions.

Join a highly experienced team in a collaborative and science-driven environment. Ideal for motivated, curious talents passionate about patient safety eager to grow in drug safety. Develop expertise while making a meaningful impact on treatments like QUVIVIQ.

Requirements

Expertise on global pharmacovigilance regulations and guidelines
Experience in safety signal management and tracking
Proficiency in preparing periodic safety reports such as DSUR and PBRER
Knowledge of MedDRA for data coding and analysis
Skills in medical writing for safety evaluation documents
Familiarity with PRAC recommendations and health authority queries
Ability to analyze safety data and product safety profiles
Current awareness of pharmacovigilance guidance and regulations

Responsibilities

Lead safety signal tracking and management, ensuring new safety signals are properly tracked, documented, and actions completed timely
Support Drug Safety Physician in medical safety evaluation of identified safety signals and preparation of responses to health authority queries
Monitor PRAC meeting documents and relevant sources, informing Drug Safety Physician and Head of GDS on safety information for Idorsia products
Coordinate planning schedule and allocation of responsibilities for periodic safety reports preparation and submission to health authorities
Act as lead author in medical writing of periodic safety reports and ad-hoc safety analysis reports in cooperation with Drug Safety Physician
Work closely with departments like DRA, Clinical Pharmacology, and Clinical Science to ensure accurate, timely contributions to safety reports
Participate in review of medical/scientific literature for inclusion in periodic safety reports
Act as MedDRA expert, participating in development, update, and maintenance of data retrieval and analysis specifications