About the company
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Director, Drug Safety Physician based in United States.
Responsibilities
- Perform triage and medical review of Individual Case Safety Reports (ICSRs)
- Oversee cases and Analysis of Similar Events (AOSEs) supporting expedited safety reporting
- Lead cross-functional medical review discussions related to ICSR assessment
- Participate in preparing, writing, and reviewing aggregate safety reports, including DSURs
- Review safety sections of clinical trial documents and regulatory submissions
- Lead or contribute to scientific literature reviews
- Participate in safety surveillance activities and evaluate emerging safety signals
- Support the assessment, management, and monitoring of identified safety signals
- Participate in and co-present cases at Safety Management Team and Safety Review Team meetings
- Develop safety presentations for independent Data Monitoring Committee meetings
- Provide medical safety input into clinical development plans, study protocols, periodic safety reports, and safety management plans
- Contribute to responses to health authority, institutional review board, and ethics committee queries
- Lead epidemiology and pharmacoepidemiology projects
- Assist with the development and maintenance of pharmacovigilance processes, SOPs, work instructions, safety management plans, and surveillance plans
Requirements
- MD or equivalent medical degree
- 6+ years of relevant clinical development drug safety or medical review experience within the biotechnology or pharmaceutical industry
- Experience with medical review of ICSRs and periodic safety reports
- Experience with late-stage or clinical development programs
- Working proficiency with the Argus global safety database
- Experience in safety surveillance and signal detection
- Strong knowledge of global pharmacovigilance regulations, including FDA and EMA expectations
- Experience with oncology, biologics, or innovative therapeutic modalities is valuable
- 2–3 years of medical device safety experience is strongly preferred
- Degree or substantial working knowledge in epidemiology or pharmacoepidemiology is highly preferred
- Ability to interpret complex safety data
- Strong analytical, critical-thinking, and problem-solving skills
- Excellent written, verbal, and interpersonal communication skills
Conditions
- Fully remote opportunity with frequent in-person collaboration
- Competitive salary range of $280,000–$311,000
- Professional development