Job Description
Description 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 Responsibilities (included but not limited to): - 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:
- Protocols and amendments
- Informed Consent Forms (ICFs)
- Investigator’s Brochures (IBs)
- Clinical Study Reports (CSRs)
- Investigational New Drug (IND) applications
- 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:
- Periodic Benefit–Risk Evaluation Reports (PBRERs)
- 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
This description is not intended to be all inclusive. Employees may perform other related duties as needed to meet the ongoing requirements of the Global Drug Safety (GDS) organization.
Education/Experience/Skills - 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
- Experience in clinical research and drug development preferred
- 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
- Experience in clinical research or pharmacoepidemiology preferred
- 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)
This description is not intended to be all-inclusive. Employees may perform other related duties as needed to meet the ongoing requirements of the Global Drug Safety (GDS) organization.
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: The base salary for this position will range from $245,000 to $275,000. Candidate experience, professional licensing, and geographic location will be taken into consideration.
Employment is contingent upon successful completion of all required screening and verification processes, including for authority to work in the United States.
EEO Statement Catalyst Pharmaceuticals is an Equal Opportunity Employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status.
Recruitment & Staffing Agencies: Catalyst Pharmaceuticals does not accept unsolicited agency resumes. Agency resumes will only be accepted if the agency is formally engaged by Catalyst Human Resources.
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