Drug Safety Case Manager Job Details | Idorsia

Poste

Temps plein

Permanent

Mid

Santé

Modalités

Allschwil, Bâle-Campagne

100%

Exigences

5+ ans d'exp.

Bachelor

Permis UE/AELE

Compétences

PharmacovigilanceData EntryCollaboration with CROsDrug Safety Case ManagementClinical trialsReconciliation processesMedizinische TerminologieQuality Review of Audit Work PapersAdverse event reportingMedical billingStandard Operating Procedures (SOPs)Safety File Management

Langues

Anglais

Description

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

Responsabilités

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
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

Exigences

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

Avantages

Opportunity to make a direct impact on patient safety while working in a dynamic, international environment
Collaborate with experienced professionals across clinical development and pharmacovigilance
Contribute to innovative clinical programs
Play a key role in ensuring the safe use of medicines

Entreprise

Idorsia

Pharmaceuticals

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.