Médecin de l'innocuité des médicaments — Idorsia Pharmaceuticals
- Lieu
- Allschwil
- Contrat
- full-time
- Publié
- Hier
Vue d’ensemble du poste
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.
Responsabilités principales
- 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
Ce que l’entreprise offre
- 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.
Processus de candidature
- 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.
Contacts
- 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.
Entreprise et contexte
- 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.
Détails supplémentaires
- 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
Notes et contenu original
- 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
Questions sur cette offre
Quel salaire propose Idorsia Pharmaceuticals pour ce poste ?
Idorsia Pharmaceuticals indique CHF 62 000 - 94 000 bruts par an pour ce poste à Allschwil. Il s'agit du salaire publié dans l'annonce d'origine (ou, si l'employeur ne précise pas de montant, d'une estimation réaliste pour le rôle et le secteur) — le calculateur de ce site le convertit en net réel une fois l'impôt frontalier et les cotisations sociales appliqués.
Est-ce un poste à temps plein, et quel type de contrat propose Idorsia Pharmaceuticals ?
Cette offre est un poste en temps plein. Le type de contrat affiché ici provient directement de l'annonce originale de l'employeur ; confirmez toujours les horaires exacts, le préavis et la durée d'essai avec Idorsia Pharmaceuticals pendant le processus de candidature, ces détails pouvant varier même au sein de la même catégorie de contrat.
Ai-je besoin d'un permis de frontalier pour un poste dans le canton de Bâle ?
Les résidents UE/AELE domiciliés dans la zone frontalière du pays voisin du canton de Bâle peuvent demander un permis G ; l'employeur suisse le dépose auprès de l'office cantonal des migrations après signature du contrat. Les règles de zone frontalière et les délais varient selon le pays voisin et le canton — confirmez les détails auprès de l'office des migrations du canton de Bâle ou avec les RH pendant la candidature.
Comment postuler à ce poste chez Idorsia Pharmaceuticals ?
Utilisez le bouton « Postuler maintenant » sur cette page — il renvoie directement à l'annonce originale de Idorsia Pharmaceuticals sur careers.idorsia.com, votre candidature arrive donc directement dans le système de suivi des candidatures de l'employeur. Frontaliere Ticino ne collecte ni ne transmet lui-même les candidatures.
