Drug Safety Physician

Catalyst Pharmaceuticals Inc • Coral Gables, FL

6d • $245,000 - $275,000

About The Position

The Drug Safety Physician will be accountable for assigned Catalyst product(s) and for the overall safety profile of those products. This role is responsible for the oversight and execution of safety surveillance activities, risk management strategies, and risk communication across products in both clinical development and post-marketing phases. The incumbent will lead the medical assessment of individual case safety reports and aggregate safety data, as well as author and/or critically review key safety deliverables. This position reports directly to the Vice President of Drug Safety.

Requirements

• Doctor of Medicine (M.D.) degree required
• Minimum of 8–10 years of experience in pharmacovigilance (PV), including medical review, aggregate safety reporting, safety evaluation, and risk management
• Advanced knowledge of global pharmacovigilance regulatory requirements, including regions such as the United States (US), European Union (EU), Latin America (LATAM), and the Asia Pacific (APAC) region
• Strong competency in understanding the scientific background of disease mechanisms and medical therapies
• Demonstrated ability to analyze and present complex safety data clearly and effectively
• Proven experience leading cross-functional safety teams
• Excellent communication, leadership, and organizational skills
• Demonstrated ability to think strategically and convey complex issues clearly to diverse audiences
• Strong understanding of the Medical Dictionary for Regulatory Activities (MedDRA) terminology and its application
• Proficiency in Microsoft Office (Word, Excel, and PowerPoint)

Nice To Haves

• Experience in clinical research and drug development preferred.
• Experience in clinical research or pharmacoepidemiology preferred

Responsibilities

• Lead medical safety assessment of individual case safety reports
• Oversee appropriate review of all safety data from various sources (e.g., pre-clinical studies, clinical trial data, post-marketing data, and published literature) throughout the development process for assigned products
• Conduct safety signal detection activities, including monitoring, evaluation, interpretation, and appropriate management and communication of safety information to the Safety Management Team (SMT) for assigned products
• Manage ongoing and cross-functional assessment of the benefit–risk profile and related actions, including writing and updating benefit–risk documents for assigned marketed products and development compounds
• Provide expert safety review input into all critical documents for clinical development of products, including: o Protocols and amendments o Informed Consent Forms (ICFs) o Investigator’s Brochures (IBs) o Clinical Study Reports (CSRs) o Investigational New Drug (IND) applications o Clinical Trial Applications (CTAs)
• Collaborate with the VP, DS to develop strategy and implementation plans for safety and benefit–risk management for assigned products
• Write and/or review key content for safety evaluation documents of assigned products.
• Lead the implementation of Risk Management Plans (RMPs) and evaluation of the effectiveness of Risk Minimization Measures (RMMs).
• Write and/or review periodic safety reports for assigned products, such as: o Periodic Benefit–Risk Evaluation Reports (PBRERs) o Development Safety Update Reports (DSURs)
• Assist in the development and maintenance of relevant policies, Standard Operating Procedures (SOPs), and work instructions
• Support inspection of readiness activities to ensure compliance with global regulatory standards

Benefits

• Catalyst is committed to providing competitive wages and comprehensive benefits including health, dental, and vision insurance, generous paid time off, a retirement savings plan with Company Match, and more.
• Further details about our benefits package can be found here: https://www.linkedin.com/company/catalystforrare/life/life-at-catalyst/?viewAsMember=true

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree
• Number of Employees: 101-250 employees