The posting
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 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.
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
RESPONSIBILITIES 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
- Strategic impact: play a key role in shaping product safety strategies across development and commercialized products
- Scientific leadership: collaborate with experienced internal and external experts on complex safety challenges
- 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. 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. 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.
