Clinical Safety Physician

A Swiss-based global biopharmaceutical company that specialises in the development and manufacture of drugs and diagnostics tools is seeking to recruit a Clinical Safety Physician. The organisation focuses on developing prescription drugs that target unmet medical needs whilst in-licensing and developing promising drug candidates. Joining the company's Clinical Safety and Pharmacovigilance team in their office in Lausanne, this role is an exciting opportunity to expand upon a career in the field of Drug Safety.

The Clinical Safety Physician will be responsible for actively managing and evaluating risks associated with products in development under the responsibility of the Head of Clinical Safety and Pharmacovigilance. They will also support deployment of the early phases in healthy volunteers in collaboration with the Clinical Pharmacology & Drug Metabolism team.

Job Responsibilities:

• Evaluating and establishing the safety profile of compounds in development in collaboration with the different company experts and/or partner vendors.
• Providing medical input with respect to safety aspects of the design and preparation of protocols, investigator brochures, study protocols, and Development safety update reports.
• Overseeing safety surveillance activities for products in development, including medical review of individual safety cases and signal detection activities (ongoing review of safety data).
• Overseeing medical aspects of assigned healthy volunteers clinical pharmacology studies, including first-in-human studies (SAD, MAD), clinical drug-drug interaction, TQT, special populations PK, and ADME studies.
• Collaborating with Clinical Operations and Program Medical Director when applicable, monitoring drug safety in early clinical phases and in late clinical pharmacology studies in healthy volunteers or patients.
• Collaborating with Clinicians, Biostatisticians, Translational Medicine, Clinical Operations, and Regulatory functions to ensure that clinical programs will support robust safety assessment of our investigational compounds.
• Collaborating with the relevant functions within Translational Medicine and Clinical Research & Development to develop the methodology for safety monitoring in clinical trials.
• Joining the global project teams and work in a collaborative and proactive way in a matrix environment.
• Participating in IDMC meeting or other safety related interactions with outside collaborators, and in internal safety task forces.
• Reviewing documentation intended for regulatory submissions, including the relevant sections of INDs and NDAs.

Skills and Requirements:

• D., with experience in clinical safety in early clinical phases of drug development in a global pharmaceutical or global CRO.
• At least 5-8 years of direct experience in Biotech/Pharmaceutical industry in clinical safety.
• Experience in hepatic and cardiac safety management.
• Hands-on experience in authoring regulatory documentation; experience in attending regulatory meetings an asset.
• Experience in anti-infective or oncology drug development and/or in clinical pharmacology is considered a plus.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Divya Mistry at +44 203 854 1080 or upload your CV on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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