Our client is a clinical-stage biopharmaceutical manufacturing company. They have asked us to assist them in their search for a Safety Physician.

Major tasks and responsibilities include :

• Develops proactive patient-centric risk management strategies for the product.
• Is responsible for the benefit-risk and product risk minimization for investigational compounds.
• Plans, manages, analyzes, and monitors Safety / PV activities for study medications.
• Oversees CRO medical monitor or directly monitor study safety related activities.
• Establishes safety analyses in the clinical trial and safety databases for monitoring.
• Is accountable for serious adverse events (SAEs) review and safety report.
• Is responsible for safety issue management, including responding to safety-related questions from regulatory agencies, stakeholders, and other parties as needed.
• Provides clinical support for required regulatory submission.
• Provides interpretation of clinical trial safety data for clinical trial reports, publications, and submission documents.
• Develops departmental SOPs and works with Quality Assurance for compliance with applicable quality and regulatory requirements.
• Provides updates of the drug’s safety profile to Senior Management.
• Leads a monthly safety data review meeting and provides guidance to clinical team as needed.
• Provides updates of the drug’s safety profile to Senior Management.
• Contributes to process optimization as needed.

We seek candidates with the following qualifications :

If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.

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