Safety Physician (7036)

CTC Resourcing Solutions; Basel-Stadt; Vor Ort; CHF 150.000 - 210.000; Vollzeit

Zusammenfassung

CTC Resourcing Solutions seeks a Safety Physician for Basel, Switzerland. This contract role offers 60-100% FTE and requires an MD with experience in early-phase clinical trials.

You will oversee safety monitoring, data review, and pharmacovigilance activities from Basel, collaborating with cross-functional teams to ensure regulatory compliance and patient safety. The successful candidate will lead or contribute to safety data interpretation, SAS/DSUR processes and clinical development

Qualifikationen

• MD required and registered/eligible to work in Switzerland/EU
• Several years of clinical research or development experience, ideally in early-phase trials
• Strong knowledge of clinical trial methodology, regulatory requirements, and GCP/GLP
• Ability to lead or contribute across cross-functional teams in multi-centre studies

Aufgaben

• Perform medical monitoring and pharmacovigilance activities including safety oversight and data review
• Provide causality assessments for safety signals
• Review coding activities (MedDRA) and ensure accurate safety reporting
• Conduct safety reviews of clinical data supporting case processing and aggregate reports
• Render medical reviews of aggregate reports (DSUR) and safety documentation
• Assist with development of project-specific procedures and safety management plans
• Contribute to design, execution, and reporting of Ph1/2 trials in I&I space
• Contribute to clinical development strategy and safety data communication
• Ensure safety/efficacy data generation per GCP/SOPs and timelines
• Collaborate with Clinical Operations and Biomarker teams to meet milestones
• Assist in creating study protocols and amendments and reviewing related documents

Kenntnisse

Pharmacovigilance

Safety monitoring

Causality assessment

GCP compliance

Cross-functional collaboration

Ausbildung

MD (Medical Doctor) degree

Tools

MedDRA

DSUR

Jobbeschreibung

Safety Physician – 7036 URA

Based in the biotech hub of Basel, Switzerland, our client is a private biotechnology company developing first-in-class antibodies. Their passionate team of immunology and inflammation experts takes immense pride not just in their scientific breakthroughs, but in how they achieve them. Driven by a shared purpose, they focus every day on creating innovative, transformative therapies that truly improve patients’ lives. Theyfoster an open, inter-disciplinary, diverse, international and creative working environment

For their team in Basel, they are looking for a Safety Physician with an advance Medical Degree and experience in early phase of clinical trials. This is a Contract role to work from their Basel office with a flexibility of 60-100% FTE

Main Responsibilities:

• Perform medical monitoring and pharmacovigilance activities (such as medical oversight of the study, eligibility checks, review safety data)
• Provide causality assessments
• Review of coding activities (MedDRA…)
• Perform safety review of clinical and diagnostic data as part of case processing and aggregate reporting
• Provide medical review of aggregate reports (DSUR…)
• Assist with generation of project specific procedures (medical review activities)
• Contribute to design, execution/conduct and report of Ph1/2 clinical trials in I&I space
• Contribute to medical team and clinical development strategy
• Ensure that safety and efficacy data is generated and analyzed according to GCP/SOPs, corporate strategy and timelines
• Work closely with cross-functional team members to ensure planning and execution of clinical trials to meet key study milestones
• Contribute to the development of statistical analysis plan, and in the review, interpretation, and communication of clinical trial data from clinical trials
• (Co)-Author and develop clinical documents like, clinical study protocols and amendments and review other clinical documents like safety management plan, medical monitoring plan
• Work closely with colleagues from Clinical Operations and Clinical Biomarker department to deliver clinical study program goals and milestones

Qualifications and Experience:

• Relevant working/residency permit or Swiss/EU-Citizenship required
• You have an advanced medical degree (MD)
• You have several years of clinical research or clinical development experience in pharmaceutical/biotechnological industry, ideally in early clinical trials
• You have strong knowledge of clinical trial methodology, regulatory and compliance requirements of clinical trials
• You have knowledge of Good Clinical Practices / Good laboratory Practices and clinical study design
• You are a talented, pro-active and passionate medical professional, inspired by our shared vision to bring innovation to patients with unmet medical needs
• You understand the framework and complexities of early clinical multi-centre trials and can deal with various CRO/CDO-related ways of working
• You have ideally experience in the autoimmune disease and/or IBD (I&I) space
• You thrive leading or being an active member of large or small diverse teams