What are the responsibilities and job description for the Drug Safety Physician position at The Carolan Group?
Job Title : Drug Safety Physician - Oncology
Location : Mountain View, CA (Hybrid)
Position Overview :
We are seeking an experienced Drug Safety Physician with expertise in oncology to join our client's team in Mountain View, CA. This hybrid role offers the opportunity to work on cutting-edge oncology therapies, contributing to the safety and success of innovative treatments that improve patient outcomes. The ideal candidate will be a licensed MD with at least 5 years of experience in drug safety within the pharmaceutical or biotechnology industry, specifically in oncology.
Key Responsibilities :
- Serve as the medical safety expert for oncology products across all stages of development and post-marketing.
- Oversee and perform medical review of individual case safety reports (ICSRs) to ensure accuracy, completeness, and compliance with regulatory timelines.
- Lead signal detection and risk management activities, including signal evaluation, safety assessments, and the development of risk mitigation strategies.
- Collaborate cross-functionally with Clinical Development, Regulatory Affairs, Pharmacovigilance Operations, Medical Affairs, and other internal stakeholders to ensure effective communication of safety concerns and plans.
- Author and contribute to aggregate safety reports (e.g., DSURs, PSURs, PADERs), safety sections of clinical study protocols, Investigator Brochures, and other regulatory documents.
- Support preparation for and participation in Health Authority meetings, inspections, and audits related to product safety.
- Provide safety input into study design, safety monitoring plans, and clinical trial conduct.
- Contribute to benefit-risk assessments of oncology products to inform decisions on development strategies and patient safety.
- Stay abreast of current oncology treatment paradigms, safety regulations, and industry best practices.
Required Qualifications :
Preferred Qualifications :
Why Join?
Location : This role is hybrid based in Mountain View, CA. Candidates must be able to work on-site part of the time.
