Clinical Safety Scientist Lead
3 days ago
Associate Director Clinical Safety Scientist
Job Summary:We are seeking an experienced Associate Director Clinical Safety Scientist to lead our clinical safety and risk management efforts. The successful candidate will be responsible for proactively performing safety surveillance and risk management in partnership with cross-functional teams to support the benefit-risk profile throughout the product lifecycle.
Key Responsibilities:- Collaborate with Product Safety Leads to plan and prioritize safety surveillance and risk management activities for assigned products.
- Oversee the coordination of Safety Management Team (SMT) meetings, maintain rosters, calendars, and minutes, and communicate materials to support the Product Safety Lead.
- Evaluate safety data to identify potential safety signals and perform safety analysis/evaluation.
- Contribute to safety action recommendations, communication, and risk minimization plans.
- Present assessments to SMT or other cross-functional teams.
- Track safety signals in the global electronic signal tracking tool.
- Collaborate with Product Safety Leads to plan and prioritize activities for Biologics License Applications (BLAs)/Marketing Authorisation Applications (MAAs), and local country submissions.
- Develop safety strategy, key safety messages, and review and author safety sections of Common Technical Document (CTD).
- Supervise a team of Clinical Safety Scientists for assigned products, or serve as a preceptor for post-doctoral fellows.
- Provide guidance, mentor, and coach junior Clinical Safety Scientists.
- Clinical development or post-marketing experience to understand safety context through the product lifecycle.
- Understanding of Safety Risk Management internal and external environment, including applicable regulations and guidances.
- Ability to engage team and cross-functional team members to facilitate continuous flow of information to meet business objectives.
- Manage conflict and negotiate constructively.
- Ability to develop and build healthy working relationships to enable higher performance.
- Effective oral and written communication skills.
- Demonstrated ability to handle more than one complex project simultaneously, prioritizing and recognizing key issues.
- Demonstrates effectiveness in working in a multidisciplinary and matrixed environment.
- Understanding of tools, standards, and approaches used to efficiently evaluate safety is desirable.
- Microsoft Word, Excel, PowerPoint skills, and Project management skills.
We are a dynamic and innovative company that values collaboration, creativity, and continuous learning. Our team is passionate about delivering high-quality results and making a meaningful impact in the industry. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity.
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