Apply📍 United States
🔍 Biopharmaceutical
- Minimum of 3 years’ experience in industry, with at least 2 years’ experience in drug safety (e.g., safety signaling, risk management and mitigation)
- Excellent medical knowledge and safety surveillance experience in nephrology or immunology preferred.
- Thorough understanding of and ability to interpret patient safety and pharmacovigilance data.
- Understanding of drug safety regulatory requirements for investigational products, including ICH, 21 CFR, and EU GVP regulations
- Experienced in safety data analysis, MedDRA coding, and global regulatory guidelines.
- Strong communication and organizational skills, with the ability to work in a fast-paced environment and adapt to changing priorities.
- Ability to collaborate with internal and external stakeholders to manage complex safety issues.
- Strong interpersonal and communication skills
- Ability to interact with all audiences and clearly and concisely present data, strategy and risk assessment.
- Accountable for and leads safety surveillance, risk assessments, and safety management for assigned products including timely and thorough safety review as the lead for the Safety Management Team meetings.
- Support decision-making through risk/benefit evaluations and safety data analysis.
- Collaborate with cross-functional teams on clinical trials, safety protocols, and patient safety issues.
- Supports the development of the clinical safety strategy to be included in the Clinical Development Plan, integrated Safety Management Plan and early phase clinical study protocols.
- Working with the Pharmacovigilance Scientist, and relevant cross-functional team members oversees the creation of Risk Management Plans.
- Develop and contribute to safety reports for regulatory submissions and periodic reports.
- Participate in audits, inspections, and maintain compliance with global pharmacovigilance regulations.
- Accountable for providing rapid and effective communication of important safety issues to PV management, with thorough analysis of the issue and proposed mitigation/ management strategies.
- Represents the project team at the enterprise level and for external safety committees and/or Health Authority interactions for issues relating to clinical safety.
Project ManagementData AnalysisCross-functional Team LeadershipCommunication SkillsAnalytical SkillsCollaborationWritten communicationRisk Management
Posted 11 days ago
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