Drug Safety Physician

Idorsia Pharmaceuticals

Allschwil, Switzerland

We are seeking an established Drug Safety Physician with extensive pharmaceutical or biotechnology industry experience to lead safety activities for assigned products across development and post-marketing phases. The successful candidate will bring deep expertise in pharmacovigilance, signal management, benefit-risk assessment, and regulatory safety reporting, combined with the ability to influence cross-functional teams and engage effectively with global health authorities.

This is an opportunity to make a significant impact on patient safety while serving as a key medical safety leader within our Global Drug Safety organization.

REQUIRED QUALIFICATIONS AND EXPERIENCE

Doctor of Medicine degree with substantial experience in global drug safety within the pharmaceutical or biotechnology industry;
Full understanding of post-marketing adverse experience reporting systems, experience in product safety monitoring and preparation of post-marketing regulatory safety reports/documents;
Excellent medical writing and presentation skills;
Excellent interpersonal, communication and negotiation skills;
Excellent organizational and planning capabilities and ability to meet timelines.

RESPONSIBILITIES AND TASKS

Accountable for all aspects of safety related primarily to assigned marketed products;
Acts as responsible DSP assigned to projects in early development;
Leads the cross-functional Safety Management Team (SMT) for assigned products; responsible for the integration, analysis, and interpretation of safety information from all sources, including preclinical throughout life cycle product management;
Coordinates and ensures good quality presentation by the SMT at Idorsia Drug Safety Committee (DSC), with an accurate review of the safety profile of the product including presentation of implemented safety measures and SMT recommendations;
Responsible for overall signal detection, monitoring, evaluation, interpretation and appropriate management of safety information;
Responsible for the preparation of aggregated periodic safety reports (DSUR, PSUR/PBRER), Reference Safety Information (RSI) section of the Investigator Brochure (IB) and contributes to other key regulatory key safety documents such as RMP;
Responsible for medical review of adverse event reports received from all sources for assigned projects/products to ensure proper coding, seriousness, expectedness and causality assessment and request medically relevant follow up information for proper documentation and evaluation of the cases;
Responsible for responses on safety inquiries from regulatory authorities;
Supports the management of regulatory Heath Authority inspections.