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 the Director of Integrated Signal Management in developing and maintaining signal management processes to maximize patient safety.
Responsibilities:
* Contribute to the planning, preparation, writing, and review of periodic aggregate safety reports.
* Collaborate with affiliates and internal partners regarding deliverables.
* Review adverse events and serious adverse events from clinical trials.
* Support review of study protocols, statistical analysis plans, and other clinical study-related documents.
* Review safety data tables, figures, and listings from clinical studies.
* Participate in developing safety-related data collection forms for clinical studies.
* Attend study team meetings as needed.
* Conduct signal detection, evaluation, and management.
* Analyze safety data to evaluate signals and collaborate on reporting results.
* Prepare safety assessment reports and other safety-related documents for regulatory purposes.
* Review safety data, literature, and other relevant information for signal detection.
* Participate in Safety Governance processes as per company procedures.
* Present safety issues and recommendations to cross-functional decision-making bodies.
* Assist in developing risk management strategies and activities.
* Contribute to risk management plans and update regional strategies as needed.
* Oversee risk minimization activities and track their implementation.
* Evaluate risk minimization efforts and prepare responses to regulatory inquiries.
* Support activities related to new drug applications and regulatory filings.
* Assist in developing safety strategies for regulatory activities and contribute safety content for filings.
* Perform additional duties as per SOPs or supervisor requests.
Requirements / Qualifications:
* Doctorate degree OR Master’s degree with 2 years relevant experience OR Bachelor’s degree with 4 years relevant experience.
Qualifications:
* Healthcare professional background.
* At least 1 year of drug safety/pharmacovigilance experience.
* Experience in signal detection, evaluation, and management.
* Contributed to periodic aggregate safety reports.
* Experience with literature surveillance and source document review.
* Familiarity with the Argus Safety database.
* Good clinical and scientific judgment.
* Clinical and/or medical research experience.
* Strong written and verbal communication skills.
Company Description
The Steely Group is a 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.
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