Senior Drug Safety Case Manager

Idorsia Pharmaceuticals Ltd; Basel; On-site; CHF 110,000 - 140,000; Full time

Job summary

Idorsia Pharmaceuticals Ltd in Basel, Switzerland is seeking a Drug Safety Case Manager to lead adverse event case management across the product lifecycle. You will collaborate with physicians, clinical teams, regulatory colleagues, and external partners to ensure timely and compliant safety reporting for both clinical trials and post-marketing cases.

The ideal candidate holds a degree in Life Sciences, Pharmacy or Nursing, has 5+ years in drug safety case management, and possesses strong

Qualifications

• Strong understanding of medical terminology, disease processes, and safety databases.
• Experience with medical coding dictionaries and safety reporting systems.
• Good knowledge of EU and US pharmacovigilance regulations and reporting requirements.
• Degree in Life Sciences, Pharmacy, Nursing, or related healthcare discipline.
• Fluent English, both written and spoken.
• EU/EFTA citizenship is required due to permit restrictions.
• Excellent organizational skills with ability to manage multiple priorities and tight deadlines.

Responsibilities

• Manage adverse event cases from receipt through submission, including triage, data entry, narrative writing, and expedited reporting.
• Prioritize safety cases in accordance with global regulations, SOPs, and timelines.
• Identify missing or incomplete information and coordinate follow-up with Drug Safety Physicians and stakeholders.
• Monitor case workflows to ensure efficient processing and compliance.
• Support reconciliation activities to ensure data consistency across systems.
• Coordinate SAE reconciliation and SUSAR notifications to investigators and Ethics Committees.

Skills

Medical terminology

Safety databases

Medical coding

Education

Life Sciences/Pharmacy/Nursing degree

Tools

Safety reporting systems

Job description

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Are 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.

Working 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.

Your Responsibilities:

Case Management & Safety Reporting

• Manage 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
• Prioritize and process safety cases in accordance with global regulations, SOPs, and reporting timelines
• Identify missing or incomplete information and coordinate follow-up activities with Drug Safety Physicians and other stakeholders
• Monitor case workflows to ensure efficient and compliant case processing
• Support or oversee reconciliation activities to ensure data consistency across systems

Clinical Trial & Cross-Functional Support

• Contribute to the successful set-up of new clinical studies by providing safety reporting documentation, reconciliation plans, monitoring guidance, and TMF documentation
• Support SAE reconciliation activities between clinical and safety databases
• Coordinate SUSAR notifications to investigators and Ethics Committees
• Collaborate with internal and external stakeholders, including CROs, to establish and maintain safety agreements and processes

What You'll Bring:

• Degree in Life Sciences, Pharmacy, Nursing, or a related healthcare discipline
• Minimum 5 years of experience in drug safety case management
• Strong understanding of medical terminology, disease processes, and safety databases
• Experience with medical coding dictionaries and safety reporting systems
• Good knowledge of EU and US pharmacovigilance regulations and reporting requirements
• Excellent organizational skills with the ability to manage multiple priorities and meet tight deadlines
• Strong attention to detail, problem-solving abilities, and a collaborative mindset
• Fluent English, both written and spoken
• EU/EFTA citizenship is required due to permit restrictions

Why Join Us?

This 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.

Business Area: Global Business Development, Drug Safety

Job ID: 4840

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.