Safety Analysis Scientist (SAS)
REMOTE, IN 00000 US
Target PR Range: 57-67
*Depending on experience
Summary: The Safety Analysis Scientist (SAS) will be responsible for core safety deliverables, including scheduled and ad hoc aggregate reports, and will serve as report owner for assigned reports (medium to large volume, standard complexity).
The SAS will have in-depth product knowledge and will support Safety Management Team (SMT) deliverables as required.
Daily activities involve planning, conducting meetings, database searching, aggregate safety analysis and case-level review (clinical trial and post-marketing data), writing, and project management/coordination of strategic safety documents.
The SAS will partner with team members, stakeholders including Medical Safety Officers (MSOs), and team members.
• Ensure timely, quality reports/safety analyses related to core deliverables with oversight as appropriate
• Strategy development for safety topics, ad hoc reports, signal evaluation
• Initiate/Conduct/Oversee searches of internal and external databases
• Perform and/or lead aggregate safety analysis and case-level review
• Author, contribute, and coordinate the preparation of core safety deliverables for aggregate reports, ad hoc reports, signal management, Health authority inquiries etc
• Ensure commitments (e.g., Pharmacovigilance Agreements (PVAs), assessment reports) are met
• Provide SMT support as needed
• Act as ad hoc member for assigned products as appropriate
• Participate in department and/or cross-functional initiatives
Decision Making/ Problem Solving
• Ability to work independently with no to minimal supervision
• Recognize potential issues and or safety issues and escalate to the attention of the report owner, line manager, or MSO
• Ability to understand the nature of adverse drug reactions and complex associations
• High level of flexibility and ability to (re)prioritize work of oneself and others
• Attention to detail and ability to analyze data in a broader context
• Ability to work across multiple functions and therapeutic areas
• Review regulatory assessor comments/requests and accommodate/address as appropriate with guidance
• Scientific Skillset: Comprehensive Analytic and Conceptual Skills
• SME-In depth product knowledge of assigned products
• Core SMT member or SMT support when needed
• Working knowledge of applicable global, regional, and local regulatory requirements (e.g., ICH guidelines)
• Strong communication skills, both written and spoken (Ability to influence others and accomplish goals in strict timelines)
• Experience in Oncology preferred
• Any other task assigned by the line manager/client
?*CO/NYC candidates might not be considered
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.