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Job Description:

Essential Job Duties and Responsibilities:
The Senior Safety Analysis Scientist (SAS) provides scientific expertise and leads the safety assessment of assigned products. The Senior Scientist SAS, in partnership with the Medical Safety Officer (MSO), is responsible for the preparation of scientific safety analysis and evaluations, which are required for regulatory compliance and to aid in safety-related decisions for marketed products and products in development.

The Senior Scientist SAS will support product Safety Management Teams (SMTs) and work in close collaboration with other cross-functional safety partners to determine a product’s safety strategy, complete safety analyses and evaluations, proactively review safety data/lead safety data review meetings and interpret safety information to make a recommendation, supporting SMT deliverables as required.

The Senior Scientist SAS will assist the MSO with activities related to the SMT and with contributions to key safety and clinical documents.

The Senior Scientist SAS will have product knowledge and will serve as product point of contact.

The Senior Scientist SAS will function independently, with frequent guidance/support from the Director, SAS Therapeutic Area Lead (TAL) or Associate Director (AD)/Manager SAS, link discussions to content, and deliver quality results with moderate guidance from AD/Manager SASs. The Senior Scientist SAS will build alliances and be able to influence other safety partners to shape decisions/outcomes.

• Lead safety evaluations, including strategy discussions, collaborating with Therapeutic Area Safety Head (TASH)/MSO and other stakeholders as necessary, data retrieval, data analysis, report writing, and report revision.
• Ensure high quality safety evaluations and reports with moderate comments from stakeholders and moderate revisions required.
• Provide support to Associate Director (AD) SAS and Manager SAS for novel projects, to create value through completion of task-based activities without defined processes.
• Provide input and review of key regulatory or clinical documents as appropriate.
• Demonstrate leadership in the SMT and support the MSO.
• Support SMT activities (e.g., preparing and presenting data, compiling meeting minutes, updating signal tracking information).
• Lead proactive safety data reviews, if applicable and form a safety position across Global Medical Safety (GMS) which can be leveraged for aggregate safety reports.
• Provide support for Health Authority interactions regarding safety and risk management, both written and verbal.
• Participate in department and/or cross-functional initiatives.
• Support audits/inspections
Minimum Qualification
• Bachelor’s Degree Required: Healthcare-related or Biomedical Science (6+ years industry experience or equivalent).
• Advanced Degree Preferred: Healthcare-related or Biomedical Science (4+ years industry experience or equivalent).
• Medical writing or Pharmacovigilance (PV) experience required.
• Clinical experience preferred.

Required Skills:
• Working knowledge of medical concepts and familiarity with safety activities in drug development and post marketing and global safety health authority requirements.
• Ability to understand and analyze complex medical-scientific data from a broad range of sources.
• Ability to interpret and present complex data to determine benefit-risk impact.
• Excellent English verbal and written communication skills.
• Ability to effectively interact with stakeholders, including business partners.
• Ability to work in a matrix environment, proven leadership skills.
• Ability to plan work to meet deadlines and effectively handle multiple priorities.
• Proficiency in Microsoft Word, Excel, and PowerPoint.
• Ability to influence, negotiate and communicate with both internal and external customers.