Medicina di sicurezza — Idorsia Pharmaceuticals
- Località
- Allschwil
- Contratto
- full-time
- Pubblicato
- Ieri
Panoramica
The purpose of Idorsia is to discover, develop and commercialize innovative medicines to help more patients.
To achieve this, we will develop Idorsia into a leading biopharmaceutical company, with a strong scientific core.
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 purpose of Idorsia is to discover, develop and commercialize innovative medicines to help more patients.
- To achieve this, we will develop Idorsia into a leading biopharmaceutical company, with a strong scientific core.
- AND TASKS
- Accountable for all aspects of safety related primarily to assigned marketed products
- 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.
Responsabilità principali
- 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 What we offer
Cosa offre l’azienda
- 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.
Processo di candidatura
- We encourage all potential candidates with diverse backgrounds of race, color, religion, sexual orientation, gender identity, age, national origin, and disability 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, of which you would be informed in greater detail in due course.
- Idorsia Pharmaceuticals Ltd ("Idorsia") is committed to a fair and transparent application process.
- In order to avoid any conflict of interest in line with Idorsia Code of Business Conduct, which would undermine such a commitment, the applicants must disclose any personal, financial, or other outside interests interfering with the interests of Idorsia.
- Further, the applicant is obliged to disclose any and all relationships with close or affiliated persons, who are employees of Idorsia or are collaborating with Idorsia in any other contractual relationship.
- Please note Idorsia operates a strictly controlled list of preferred recruitment partners.
Contatti
- 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.
Azienda e contesto
- 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
- Global environment : work in a highly international organization with broad cross-functional exposure Work Location: Allschwil, Switzerland Business Area: Global Drug Safety Job Type: Permanent, full time Job ID : 4838
- At Idorsia, we harness the power of difference, authenticity, and inclusion to achieve business success.
Dettagli ulteriori
- 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 RESPONSIBILITIES AND TASKS
- Supports the management of regulatory Heath Authority inspections
- Global environment : work in a highly international organization with broad cross-functional exposure Work Location: Allschwil, Switzerland Business Area: Global Drug Safety Job Type: Permanent, full time
Note e contenuto originale
- 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
- RESPONSIBILITIES AND TASKS
- What we offer
- Global environment : work in a highly international organization with broad cross-functional exposure
- Work Location: Allschwil, Switzerland
- Business Area: Global Drug Safety
- Job Type: Permanent, full time
- Job ID : 4838
Domande frequenti su questo annuncio
Che stipendio offre Idorsia Pharmaceuticals per questa posizione?
Idorsia Pharmaceuticals indica CHF 62'000 - 94'000 lordi annui per questo ruolo a Allschwil. Questo è lo stipendio pubblicato nell'annuncio originale (o, quando il datore non specifica una cifra, una stima realistica per ruolo e settore) — il calcolatore di questo sito lo converte nel netto reale una volta applicate imposta da frontaliere e contributi sociali.
È un ruolo a tempo pieno, e che tipo di contratto offre Idorsia Pharmaceuticals?
Questo annuncio è una posizione a tempo pieno. Il tipo di contratto mostrato qui arriva direttamente dall'annuncio originale del datore di lavoro; conferma sempre orario esatto, preavviso e durata del periodo di prova con Idorsia Pharmaceuticals durante il colloquio, perché questi dettagli possono variare anche all'interno della stessa categoria contrattuale.
Serve un permesso da frontaliere per un ruolo nel canton Basilea?
I residenti UE/AELS nella zona di frontiera del paese confinante con il canton Basilea possono richiedere il Permesso G; il datore di lavoro svizzero lo presenta all'ufficio della migrazione di quel canton dopo la firma del contratto. Regole sulla zona di frontiera e tempi di lavorazione variano per paese confinante e canton — verifica i dettagli con l'ufficio della migrazione del canton Basilea o con HR durante il colloquio.
Come mi candido a questa posizione presso Idorsia Pharmaceuticals?
Usa il pulsante "Candidati ora" in questa pagina — rimanda direttamente all'annuncio originale di Idorsia Pharmaceuticals su careers.idorsia.com, quindi la tua candidatura arriva direttamente nel sistema di gestione candidature del datore di lavoro. Frontaliere Ticino non raccoglie né inoltra candidature in proprio.
