Job Description
Job Description
This global patient safety scientist position guides and leads safety signal management processes and activities reporting to the Director, Integrated Signal Management. The person in this role ensures that safety signal management processes are continuously improved to reflect regulatory trends and guidelines and represent best in class. Supports Director Integrated Signal Management in developing and maintaining signal management processes to maximize patient safety.
Responsibilities:
- Contributes to the planning, preparation, writing and review of periodic aggregate safety reports.
- Works with affiliates and other internal partners regarding deliverables.
- Review of adverse events and serious adverse events from clinical trials.
- Review and provide input and support on study protocols, statistical analysis plans and other clinical study-related documents
- Review standard design of tables, figures, and listings for safety data from clinical studies
- Participate in development of safety-related data collection forms for clinical studies
- Attend study team meetings as requested or needed
- Conduct signal detection, evaluation, and management
- Perform data analysis to evaluate safety signals and write up analysis results in collaboration with GSO
- Prepare safety assessment reports and other safety documents and regulatory responses
- Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection
- Participates in Safety Governance per company processes
- Prepare presentation of the Global Safety Team’s recommendations on safety issues to the cross-functional decision-making body
- Assist GSOs and other Senior Scientists in the development of risk management strategy and activities
- Provides contents for risk management plans
- Update strategy and content for regional risk management plans
- Assist GSOs to oversee risk minimization activities including tracking of activities as needed
- Evaluate risk minimization activity
- Prepare response to regulatory inquiries related to risk management plans under the guidance of GSO
- Support activities related to new drug applications and other regulatory filings
- Assist GSO/ or other Senior Scientist in developing a strategy for safety-related regulatory activities
- Provide safety contents for filings
- Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by the supervisor
Requirements / Qualifications:
- Doctorate degree OR Master’s degree and 2 years of relevant experience OR Bachelor’s degree and 4 years of relevant experience
Preferred Qualifications:
- Healthcare professional background
- 1 year of drug safety/PV experience
- Experience in signal detection, evaluation and management
- Experience as a contributor to periodic aggregate safety reports
- Experience with literature surveillance: source document review, knowledge, and skills
- Experience with the Argus Safety database
- Good clinical and scientific judgment
- Clinical and/or medical research experience
- Strong written and verbal communication skills
Company DescriptionThe Steely Group is a national preclinical, clinical, and commercial staffing firm and certified women’s business enterprise. We partner with small, growing biotech, pharma, and gene therapy companies to help bring treatments to patients by providing flexible talent acquisition solutions including Contingent Search (Direct Hire & Contract Consultants) and Retained Executive Search.
Company Description
The Steely Group is a national preclinical, clinical, and commercial staffing firm and certified women’s business enterprise. We partner with small, growing biotech, pharma, and gene therapy companies to help bring treatments to patients by providing flexible talent acquisition solutions including Contingent Search (Direct Hire & Contract Consultants) and Retained Executive Search.