Safety Physician – 7036 URA

CTC Resourcing Solutions; Basel; Vor Ort; CHF 120.000 - 240.000; Vollzeit

Zusammenfassung

CTC Resourcing Solutions is supporting Basel-based biotech in its search for a Safety Physician. The role is a Basel office-based contract with 60-100% FTE, requiring an advanced medical degree (MD) and experience in early clinical trials.

You will oversee medical monitoring and pharmacovigilance, provide causality assessments, review safety data and MedDRA coding, and help shape trial design and safety documentation in collaboration with cross-functional teams.

Qualifikationen

• Advanced medical degree (MD) required.
• Several years of clinical research or development experience, ideally in early trials.
• Knowledge of GCP/GxP and regulatory requirements.

Aufgaben

• Medical monitoring and pharmacovigilance activities including safety data review.
• Provide causality assessments and safety reviews of data.
• Review coding activities (MedDRA) and contribute to safety documents.
• Contribute to design and conduct of Ph1/2 trials in I&I space.
• Ensure data generation and analysis align with GCP/SOPs and timelines.

Kenntnisse

Medical monitoring

Pharmacovigilance

Regulatory knowledge

GCP compliance

Ausbildung

MD

Swiss/EU permit

Tools

MedDRA

Jobbeschreibung

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. They foster 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