Senior Medical Director, Pharmacovigilance And Patient Safety

10+ years

$320,000 - $340,000

Brisbane

10 Feb. 14, 2025

Job Description

Job Type: Full Time Education: MD/MBBS/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

Senior Medical Director, Pharmacovigilance and Patient Safety
Company: Day One Biopharmaceuticals
Location: Brisbane, CA, USA (Remote)

Position Summary:
Day One Biopharmaceuticals is seeking a hands-on Senior Medical Director, Pharmacovigilance and Patient Safety (PPS) to lead medical safety activities for assigned drug projects and products. The role involves providing drug safety expertise, guiding clinical development teams, and implementing risk management initiatives in compliance with global regulatory requirements. The ideal candidate will possess strong attention to detail, a sense of ownership, and the ability to engage proactively with cross-functional teams. This position reports to the VP, Pharmacovigilance and Patient Safety and may be fully remote. Travel of 10%-15% is typically required for in-person meetings and conferences.

Essential Duties and Responsibilities:

Evaluate clinical implications of safety data from various sources to predict safety profiles.
Escalate key safety topics and issues to leadership as needed.
Oversee medical review of case narratives for accuracy and signal detection.
Interpret aggregate safety data for periodic reports and new signal evaluations.
Lead signal detection, data analysis, and benefit-risk evaluations for assigned compounds.
Implement risk management and mitigation activities, including Risk Management Plans.
Provide medical input on data sources and evaluation of signals.
Present safety data to Data Monitoring Committees and internal Safety Assessment Committees.
Oversee vendors and contractors, including CROs involved in safety reporting.
Collaborate with cross-functional project teams and provide pharmacovigilance expertise.
Maintain pharmacovigilance systems and ensure compliance with regulatory guidelines.
Write and review safety sections of regulatory documents.
Support regulatory authority and ethics board correspondence.
Contribute to SOP updates, audits, and inspection readiness.
Maintain expertise in relevant therapeutic areas through continued learning and industry engagement.
Ensure compliance with Good Vigilance/Pharmacovigilance Practices.

Qualifications:

Medical Degree (MD, MBBS, DO) with clinical experience required.
Training in epidemiology, pharmacology, or MPH is a plus.
10+ years of experience in medical safety, with oncology expertise preferred.
6+ years of industry experience, preferably in small biotech.
Leadership, mentorship, or managerial experience preferred.
Comprehensive knowledge of clinical research, global regulatory requirements, and pharmacovigilance practices.
Strong communication, analytical, and independent decision-making skills.
Experience with industry-standard pharmacovigilance databases (PVCM preferred).
Ability to work in a fast-paced environment and manage multiple priorities.

Interview Integrity:
Day One Biopharmaceuticals conducts multiple interviews and background verification to ensure authenticity in candidate qualifications and experiences.

Compensation and Benefits:

Salary Range: $320,000 - $340,000 (based on various factors).
Competitive benefits available at https://www.dayonebio.com/benefits.

Disclaimer:
Day One Biopharmaceuticals is an equal opportunity employer committed to mutual respect and compliance with applicable laws. Employment requires full COVID-19 vaccination, with reasonable accommodations considered. Sponsorship for work visas is not available.

Recruitment & Staffing Agencies:
Unsolicited resumes from agencies will not be accepted or subject to referral fees.

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Senior Medical Director, Pharmacovigilance And Patient Safety

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