AD, Safety Analysis Scientist - 2406181250WDescriptionLead 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 minimal comments from stakeholders and minimal revisions required.
Provide input and review to 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 GMS which can be leveraged for aggregate safety reports.
Provide support for Health Authority interactions regarding safety and risk management, both written and verbal.
Assume responsibility for novel projects, create value and innovate without defined processes. May seek guidance from Directors (i.e SAS TAL) for complex projects.
Lead cross-functional training of relevant stakeholders.
Act as product or process Subject Matter Expert (SME) for audits/inspections.
Participate in, or lead, department and/or cross-functional initiatives.
Explore innovative ways of presenting data, preparing reports, and improving efficiencies within the programs they own.
Assist Directors in the creation, review and implementation of controlled documents and other related tools.
Management of unscheduled reports within the Aggregate Report Calendar.
Management activities within smaller Therapeutic Areas, as applicable.
Line-management of contractor positions within the team, as applicable.
Act as backup to TAL as needed (e.g., Director SAS TAL is unavailable)
Oversight of deliverables by other team members (e.g. complex reports), as needed
Qualifications
Bachelor’s Degree Required: Healthcare-related or Biomedical Science (11 years industry experience or equivalent).
Advanced Degree Preferred: Healthcare-related or Biomedical Science (8 years industry experience or equivalent).
Medical writing or 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 disciplines.
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 applications (e.g. Word, Excel, and PowerPoint).
Ability to independently influence, negotiate and communicate with both internal and external customers.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.Primary Location NA-US-Pennsylvania-HorshamOrganization Janssen Research & Development, LLC (6084)Job Function PharmacovigilanceReq ID: 2406181250W