Remote Safety Physician - Clinical Pharmacovigilance & Trials

Ridgeline Discovery GmbH; Basel; Vor Ort; CHF 150.000 - 210.000; Vollzeit

Benefits dieser Stelle

Prime Location Basel

Commuter Benefits

Flexible Working

Annual Leave 24 days

Zusammenfassung

GRANITE BIO, Basel-based private biotechnology company, seeks a medical professional to lead clinical monitoring and pharmacovigilance across early-phase immunology and inflammation studies. You will collaborate with physicians, CROs, and internal teams to ensure safety and data integrity.

Responsibilities include reviewing safety data, contributing to study design and protocol development, and ensuring GCP/SOP compliance.

Qualifikationen

• Advanced medical degree (MD).
• At least 1 year of clinical research or clinical development experience in pharmaceutical/biotechnological industry, ideally in early clinical trials.
• Ability to develop collaborative relationships with physicians, expert consultants and vendors.
• Strong analytical mindset and excellent written/verbal communication skills.
• Exceptional attention to detail, organizational skills and judgment.
• Strong knowledge of clinical trial methodology, regulatory requirements, and Good Clinical Practices (GCP).
• Experience with autoimmune disease/IBD (I&I) space preferred.
• Effective communicator, team player, and comfortable in ambiguous environments.

Aufgaben

• Medical monitoring and pharmacovigilance activities (oversight of studies, eligibility checks, review safety data).
• Provide causality assessments.
• Review of coding activities (MedDRA).
• Perform safety review of clinical and diagnostic data.
• Medical review of aggregate reports (DSUR).
• Assist with development of project-specific procedures (medical review).
• Contribute to design, execution, and reporting of Phase 1/2 trials in I&I space.
• Contribute to medical team and clinical development strategy.
• Ensure safety and efficacy data generation and analysis per GCP/SOPs and timelines.
• Collaborate with cross-functional teams to meet study milestones.
• Contribute to development of statistical analysis plans and interpretation of trial data.
• Prepare and review clinical documents like protocols and amendments.

Kenntnisse

Medical monitoring

Pharmacovigilance

Safety data review

Regulatory compliance

GCP

Ausbildung

MD

Tools

MedDRA

Jobbeschreibung

GRANITE BIO, Basel-based private biotechnology company, seeks a medical professional to lead clinical monitoring and pharmacovigilance across early-phase immunology and inflammation studies. You will collaborate with physicians, CROs, and internal teams to ensure safety and data integrity.

Responsibilities include reviewing safety data, contributing to study design and protocol development, and ensuring GCP/SOP compliance.