Clinical Safety Physician

vor 4 Wochen

Basel, Schweiz Manpower Vollzeit

Do you want to join VecturaFertinPharma (Philip Morris)? We're looking for a:
**Your mission**
Duration : open-ended contract through Manpower

Location : Basel or Neuchâtel or Remote

In this role as Clinical Safety Physician you are responsible for implementing and overseeing all areas of safety monitoring and reporting for clinical trials for Vectura Fertin Pharma (VFP). You will part of the submission team as a Clinical Safety expert.

**Your profile**
- Assist with development and review of all safety relevant content or safety relevant documents during the process of CSR writing and NDA submission (ISS, CO, RMP, REMS, labelling documents)
- Participate in designing and implementing Post-Authorization safety studies or other safety commitments
- Assist with development and review of all safety relevant content or safety relevant documents during clinical development (e.g. clinical study protocols, Investigator Brochures, safety management plans etc.), including coordination and oversight of all safety relevant study set up activities for assigned indications.
- Responsible for Medical monitoring of clinical study safety data
- Review and approve safety reports prior to submission
- Assess, critically review and sign off serious adverse event (SAE) case reports
- Responsible for the preparation/review of periodic safety reports
- Responsible for answering regulatory safety queries
- Provide sponsor oversight of CRO activities related to clinical safety and SAE processing by outsourced vendors
- Interface with Contract Research Organizations (CROs), and clinical operations team members
- Support the data preparation, set up and running of Data Monitoring Committees for clinical trials
- Develop and maintain an expert understanding of the safety profile of the assigned product(s) as well as understanding of the relevant disease(s) under study
- Ensure activities comply with the applicable VFP Quality System requirements and support inspections and audits
- Medical degree (MD) or international equivalent required.
- Minimum of 5 years of drug safety experience including 3 years in active clinical trial setting. Submission experience preferred but not mandatory.
- Clinical or industry experience in respiratory and/or device vigilance is an asset.
- Understanding of ICH guidelines, FDA and EMA regulatory systems for clinical trials would be required.
- Experience working per Good Clinical Practice
- Proficiency with standard office skills, standard desktop computing programs and medical terminology
- Highly organized and demonstrates understanding of workflow prioritization
- Fluency in English (verbal and written) is essential

**Interested?**
Don't hesitate to apply.

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