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Drug Safety Physician

The Carolan Group
The Carolan Group
5+ years
Not Disclosed
10 Dec. 24, 2024
Job Description
Job Type: Full Time Education: MD/DO Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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 team in Mountain View, CA. This hybrid role offers the opportunity to contribute to cutting-edge oncology therapies, ensuring the safety and success of innovative treatments that improve patient outcomes. The ideal candidate will have 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 medical review of individual case safety reports (ICSRs) for accuracy, completeness, and compliance with regulatory timelines.
  • Lead signal detection and risk management activities, including signal evaluation, safety assessments, and development of risk mitigation strategies.
  • Collaborate with Clinical Development, Regulatory Affairs, Pharmacovigilance Operations, Medical Affairs, and other stakeholders to communicate safety concerns.
  • Author and contribute to safety reports (e.g., DSURs, PSURs, PADERs), safety sections of clinical protocols, Investigator Brochures, and regulatory documents.
  • Support preparation for Health Authority meetings, inspections, and audits related to product safety.
  • Provide safety input into study design, safety monitoring plans, and clinical trials.
  • Contribute to benefit-risk assessments for oncology products.
  • Stay current on oncology treatment paradigms, safety regulations, and best practices in the field.

Required Qualifications:

  • MD (Doctor of Medicine) degree.
  • Minimum 5 years of experience in drug safety or pharmacovigilance in the pharmaceutical or biotech industry.
  • Demonstrated experience in oncology (clinical or pharmaceutical).
  • Solid understanding of global pharmacovigilance regulations and reporting requirements.
  • Strong ability to analyze and interpret complex safety data.
  • Excellent organizational and communication skills.
  • Proficiency in preparing safety documents, risk management plans, and regulatory submissions.

Preferred Qualifications:

  • Board certification in oncology or a related specialty.
  • Experience in clinical development or post-marketing pharmacovigilance for oncology therapies.
  • Familiarity with signal detection methodologies, benefit-risk analysis, and safety database systems.

Why Join?

  • Work on transformative oncology therapies with a dynamic and collaborative team.
  • Competitive compensation, benefits, and professional growth opportunities.
  • Hybrid work environment with flexibility and support.
  • Join a mission-driven company committed to advancing cancer care and improving patient lives.

Location: Hybrid position in Mountain View, CA. Candidates must be able to work on-site part-time.

If you are an experienced Drug Safety Physician with a passion for oncology, we invite you to apply today!