Senior Drug Safety Case Manager

pSelect how often (in days) to receive an alert: /p pAre you passionate about patient safety and ensuring that medicines are monitored to the highest standards? As a Drug Safety Case Manager, you will play a critical role in safeguarding patients by ensuring accurate and timely management of safety information throughout the product lifecycle. /p pWorking within a collaborative and highly skilled Drug Safety team, you will take ownership of adverse event case management activities while partnering closely with physicians, clinical teams, regulatory colleagues, and external partners to ensure compliance with global pharmacovigilance requirements. /p h3Your Responsibilities: /h3 h3Case Management Safety Reporting /h3 ul liManage adverse event cases from receipt through submission, including triage, data entry, medical coding, narrative writing, quality review, and expedited reporting for both clinical trial and post-marketing cases /li liPrioritize and process safety cases in accordance with global regulations, SOPs, and reporting timelines /li liIdentify missing or incomplete information and coordinate follow-up activities with Drug Safety Physicians and other stakeholders /li liMonitor case workflows to ensure efficient and compliant case processing /li liSupport or oversee reconciliation activities to ensure data consistency across systems /li /ul h3Clinical Trial Cross-Functional Support /h3 ul liContribute to the successful set-up of new clinical studies by providing safety reporting documentation, reconciliation plans, monitoring guidance, and TMF documentation /li liSupport SAE reconciliation activities between clinical and safety databases /li liCoordinate SUSAR notifications to investigators and Ethics Committees /li liCollaborate with internal and external stakeholders, including CROs, to establish and maintain safety agreements and processes /li /ul h3What You'll Bring: /h3 ul liDegree in Life Sciences, Pharmacy, Nursing, or a related healthcare discipline /li liMinimum 5 years of experience in drug safety case management /li liStrong understanding of medical terminology, disease processes, and safety databases /li liExperience with medical coding dictionaries and safety reporting systems /li liGood knowledge of EU and US pharmacovigilance regulations and reporting requirements /li liExcellent organizational skills with the ability to manage multiple priorities and meet tight deadlines /li liStrong attention to detail, problem-solving abilities, and a collaborative mindset /li liFluent English, both written and spoken /li liEU/EFTA citizenship is required due to permit restrictions /li /ul h3Why Join Us? /h3 pThis role offers the opportunity to make a direct impact on patient safety while working in a dynamic, international environment. You will collaborate with experienced professionals across clinical development and pharmacovigilance, contribute to innovative clinical programs, and play a key role in ensuring the safe use of medicines. /p h3Business Area: Global Business Development, Drug Safety /h3 h3Job ID: 4840 /h3 pbAt Idorsia, we harness the power of difference, authenticity, and inclusion to achieve business success.br/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.br/We are committed to fostering respect, fairness, and equal opportunities for all job applicants and our employees. /b /p pPlease 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. /p pIdorsia 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. /p pPlease 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. /p #J-18808-Ljbffr