Drogensicherheit Arzt — Idorsia Pharmaceuticals
- Ort
- Allschwil
- Vertrag
- full-time
- Veröffentlicht
- Gestern
Rollenüberblick
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.
Hauptaufgaben
- 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
Was das Unternehmen bietet
- 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.
Bewerbungsprozess
- 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.
Kontakte
- 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.
Unternehmen und Kontext
- 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.
Weitere Details
- 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
Notizen und Originalinhalt
- 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
Fragen zu dieser Stellenanzeige
Welches Gehalt bietet Idorsia Pharmaceuticals für diese Stelle?
Idorsia Pharmaceuticals gibt CHF 62'000 - 94'000 brutto pro Jahr für diese Position in Allschwil an. Dies ist das im Original-Inserat veröffentlichte Gehalt (oder, falls der Arbeitgeber keinen Betrag nennt, eine realistische Schätzung für Rolle und Branche) — der Rechner auf dieser Seite berechnet daraus Ihr tatsächliches Netto nach Grenzgänger-Steuer und Sozialabgaben.
Ist das eine Vollzeitstelle, und welchen Vertragstyp bietet Idorsia Pharmaceuticals?
Diese Stelle ist eine Vollzeit-Position. Der hier angezeigte Vertragstyp stammt direkt aus dem Original-Inserat des Arbeitgebers; klären Sie genaue Arbeitszeiten, Kündigungsfrist und Probezeit während des Bewerbungsprozesses mit Idorsia Pharmaceuticals, da diese Details auch innerhalb derselben Vertragskategorie variieren können.
Brauche ich eine Grenzgänger-Bewilligung für eine Stelle im Kanton Basel?
EU/EFTA-Bürger mit Wohnsitz in der Grenzzone des an den Kanton Basel angrenzenden Landes können eine G-Bewilligung beantragen; der Schweizer Arbeitgeber reicht sie nach Vertragsunterzeichnung beim Migrationsamt dieses Kantons ein. Grenzzonen-Regeln und Bearbeitungszeiten variieren je nach Nachbarland und Kanton — klären Sie die Details mit dem Migrationsamt des Kantons Basel oder mit HR während der Bewerbung.
Wie bewerbe ich mich für diese Stelle bei Idorsia Pharmaceuticals?
Nutzen Sie die Schaltfläche "Jetzt bewerben" auf dieser Seite — sie führt direkt zum Original-Inserat von Idorsia Pharmaceuticals unter careers.idorsia.com, sodass Ihre Bewerbung direkt im Bewerbermanagementsystem des Arbeitgebers landet. Frontaliere Ticino sammelt oder leitet keine Bewerbungen selbst weiter.
