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Sr. Director of Drug Safety Risk Management
2 months ago
Sr. Director of Drug Safety Risk Management
Status: FTE/Full time/direct hire
Comp: 220k - 250k DOE
Position Overview:
The individual in this leadership role will oversee a comprehensive system for monitoring and managing risks associated with both marketed and investigational products. This includes responsibility for signal detection, safety assessments, and guiding related activities within the organization. The role involves ensuring that all risk management planning and execution align with relevant regulations and industry standards across the US, EU, and globally. The successful candidate will maintain deep expertise in pharmacovigilance, ensuring that robust safety monitoring and risk mitigation strategies are in place. They will also lead projects focused on developing and implementing epidemiological methods and technologies to assess potential risks effectively.
Key Responsibilities:
- Lead the creation and management of an advanced system for detecting, assessing, and minimizing risks across the product portfolio.
- Serve as a key member of internal safety and risk committees, contributing to multidisciplinary teams as needed.
- Ensure all risk management activities comply with relevant international regulations and guidelines, including those in the US and EU.
- Support regulatory submissions, including applications for marketing authorization and new drug/biologic licenses.
- Manage various safety-related committees and ensure that safety signals are properly documented and addressed.
- Oversee the development of risk management strategies, including REMS, when necessary, and ensure effective delivery of these strategies.
- Collaborate with stakeholders to prepare periodic safety reports and ensure accurate data analysis.
- Provide expert safety analysis and respond to regulatory inquiries as required.
- Direct and collaborate on the development of Risk Management Plans for marketed and investigational products, ensuring all post-authorization commitments are met.
- Work with safety physicians to produce and manage safety discussion documents and track safety signals.
- Provide internal expertise in epidemiology and collaborate with other departments on relevant projects.
- Assist in clinical trial planning by advising on risk management strategies and epidemiological research methods.
- Estimate incidence and prevalence of health conditions and analyze disease-specific risk factors.
- Support health authority safety data requests and contribute to manuscript preparation for publication.
- Advise on the identification and assessment of safety risks, study design, and data interpretation.
- Collaborate with safety systems programmers to develop standard adverse event tables for signal detection.
- Draft and revise standard operating procedures related to risk management and epidemiology.
- Work with cross-functional teams to design, implement, and publish study results.
Qualifications and Experience:
- A Master’s Degree in Public Health or a related field is required, with 10 years of progressive experience in applied epidemiology within a regulated biotech or pharmaceutical industry, or a PhD with 4 years of similar experience.
- Prior experience in drug safety and risk management is strongly preferred.
- Expertise in regulatory requirements and pharmacovigilance is essential.
- Proficiency in data analysis and experience with publishing research and presenting at scientific meetings is highly desirable.
- Must be skilled in MS Office and familiar with standard pharmacovigilance tools like Argus and Arisg.
- Experience with safety signal management tools such as Empirica, Topics, or Spotfire is preferred.
- Excellent written and verbal communication skills, with the ability to clearly convey findings and recommendations.
