Idorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients.
In order to achieve this, we will develop Idorsia into one of Europes leading biopharmaceutical company, with a strong scientific core.
Headquartered in Switzerland - a European biotech hub - Idorsia is specialized in the discovery and development of small molecules, to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team, a fully-functional research center, and a strong balance sheet the ideal constellation to bringing R&D efforts to business success.
Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 600 highly qualified specialists dedicated to realizing our ambitious targets.
Accountable for all aspects of safety related to the assigned projects/products including medical assessment, aggregate reporting, signal detection, risk management, and risk minimization activities throughout the products life cycle
Leads the cross-functional Safety Management Team (SMT) for assigned projects/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
Provide drug safety expertise in all phases of drug development
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 contribute to other key regulatory key safety documents
Review, contribute and provide medical and safety expertise for study synopsis, protocol, Core Informed Consent (CIC), Briefing Book (BB), Clinical Development Plan (CDP), Clinical Study Report (CSR), Investigational Medicinal Product Dossier (IMPD), Statistical Analysis Plan (SAP) and Pediatric Investigation Plan (PIP) as required
Represents Idorsia in interactions with Health Authorities and Independent Data Safety Monitoring
Responsible for responses on safety inquiries from regulatory authorities or health careprofessionals
Doctor of Medicine degreewith at least 7-year experience in clinical and post-marketing safety and/or clinical development in the pharmaceutical or biotechnology industry
Broad scientific background and excellent clinical development knowledge, experience and ability to interpret clinical study safety information
Possessing extensive medicinal product and disease knowledge based on didactic and clinical experience, with considerable additional expertise in safety surveillance and pharmacovigilance
Full understanding of the clinical trials and post-marketing adverse experience reporting systems, experience in product safety monitoring and preparation of investigational and post-marketing regulatory safety reports/documents
Knowledge of global safety regulations, Good Clinical Practice (GCP) and Pharmacovigilance compliance requirements
Previous experience with regulatory filing and contribution to key safety documents
Good experience and knowledge with safety signal identification methodology and risk minimization measures
Excellent medical writing, presentation and communication skills
What Idorsia offers
Exciting opportunities for development and professional growth within our dynamic organization
A collaborative and solution oriented enviroment where you can make a difference
An innovative and open culture in a truly multicultural environment
A competitive salary and generous social benefits
Work Location: Allschwil
Business Area:Global Clinical Development
Job Type: Permanent
Job ID: 1030
If you are interested, please click on apply now.
Please be informed that if you are selected for this position, your employment will be subject to a pre-employment background screening process, of which you would be informed in greater detail in due course.
Please note Idorsia operates a strictly-controlled list of preferred recruitment partners. For those partners who have no valid, signed Master Service Agreement in place with Idorsia all unsolicited resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to personal e-mail accounts of employees of Idorsia Pharmaceuticals (including any of its subsidiaries, affiliates or related companies) are considered the property of Idorsia Pharmaceuticals and are not subject to payment of any form of introduction, placement or referral fees.