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Headquartered near Basel, Switzerland – a European biotech hub – Idorsia has a highly experienced team of dedicated professionals, covering all disciplines from bench to bedside; QUVIVIQ (daridorexant), a different kind of insomnia treatment with the potential to revolutionize this mounting public health concern; strong partners to maximize the value of our portfolio; a promising in-house development pipeline; and a specialized drug discovery engine focused on small-molecule drugs that can change the treatment paradigm for many patients.
Key Responsibilities
* Leading signal management activities.
* Planning and writing periodic safety reports (DSUR, PBRER).
* Supporting the Drug Safety Physician in safety data analysis and review of product safety profiles.
* Providing expertise on global safety regulations and guidelines.
Safety Signal Tracking and Management:
* Acts as the Secretary of Idorsia Drug Safety Committee (DSC) evaluating the safety profile of Idorsia compounds (investigational and marketed).
* Supports Drug Safety Physician in medical safety evaluation of identified safety signals and preparation of responses to safety queries requested by HAs.
* Acts as the safety signal tracking and management lead ensuring that new safety signals identified are properly tracked and documented.
* Monitors PRAC meeting documents or any other relevant sources and informs the responsible Drug Safety Physician and the Head of GDS of any relevant safety information for products of interest for Idorsia.
Periodic Safety Reporting and Medical Writing:
* Coordinates the planning schedule and allocation of responsibilities for regulatory aggregated periodic safety reports preparation and submission to HAs.
* Works closely with other departments/functions involved in the preparation of aggregated periodic safety reports to ensure accurate and timely contributions.
* Acts as the lead author in cooperation with the responsible Drug Safety Physician in the medical writing of periodic safety reports or other ad-hoc safety analysis reports.
* Participates in the review of medical/scientific literature relevant for inclusion in periodic safety reports.
* Collaborates with colleagues in DRA to ensure timely regulatory submission of periodic safety reports.
* Supports the Drug Safety Physician in the preparation of other types of filing and submission documents to Regulatory bodies.
Additional Responsibilities:
* Performs mentoring of Safety Scientist or related functions, as appropriate.
* Acts as MedDRA expert and participates in the development, update, and maintenance of specifications for data retrieval and analysis.
* Remains current on relevant pharmacovigilance regulations and guidance.
* Serves as the subject matter lead and expert for improvement initiatives related to Health Authorities Pharmacovigilance inspections and audits.
Candidate Requirements
* University degree in life science (e.g., pharmacy, nursing, M.Sc., or Ph.D.) or equivalent education in a health-related field with at least 10 years of experience in pharmacovigilance in the pharmaceutical industry.
* Excellent medical writing skills and previous experience in writing regulatory safety documents.
* Solid knowledge of clinical trial and post-marketing regulatory safety regulations and guidelines.
* Excellent communication, interpersonal and problem-solving skills.
* Strong organizational skills and ability to work within tight timelines with effective project management skills.
* Effective communication in English (both verbally and in writing).
* Excellent knowledge of MedDRA coding thesauri and SMQs and WHO drug dictionary and SDGs.
* Strong analytical skills with attention to details.
Business Area: Global Clinical Development, Drug Safety
Job Type: Permanent
Job ID: 4531
At Idorsia, we harness the power of difference, authenticity, and inclusion to achieve business success. We encourage all potential candidates with diverse backgrounds to submit their job applications. All applicants will receive consideration. We are committed to fostering respect, fairness, and equal opportunities for all job applicants and our employees.
Please be informed that if you are selected for this position, your employment will be subject to a pre-employment background screening process.
Idorsia Pharmaceuticals Ltd is committed to a fair and transparent application process. Applicants must disclose any personal, financial, or other outside interests interfering with the interests of Idorsia. Further, the applicant is obliged to disclose any relationships with close or affiliated persons, who are employees of Idorsia.
Please note Idorsia operates a strictly controlled list of preferred recruitment partners. All unsolicited resumes or candidate details submitted through our website or to personal e-mail accounts of employees of Idorsia are considered the property of Idorsia Pharmaceuticals.
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