Associate Director, Safety Analysis Scientist
5 months ago
**Associate Director Safety Analysis Scientist**:
Johnson & Johnson Innovative Medicine is recruiting for an **Associate Director Safety Analysis Scientist (AD SAS) **, located within commutable distance of High Wycombe, UK. The AD SAS provides scientific expertise and leads the safety assessment of assigned products. In partnership with the Medical Safety Officer (MSO), you will prepare 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 AD 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 results.
The AD SAS will assist the MSO with activities related to the SMT and with contributions to key safety and clinical documents.
The AD SAS will have in-depth product knowledge, will serve as product point of contact, and will provide training to, and oversight of deliverables prepared by other team members as needed (for complex reports).
**Principal responsibilities**:
- Lead safety evaluations, from strategy discussions, data retrieval, data analysis, report writing, to report revisions.
- Ensure high-quality safety reports with mínimal stakeholder input and revisions.
- Review regulatory or clinical documents as needed.
- Demonstrate leadership in the SMT (e.g. preparing and presenting data, compiling meeting minutes, updating signal tracking information) and support the MSO.
- Lead proactive safety data reviews and form a safety position across GMS which can be leveraged for aggregate safety reports.
- 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 and lead/participate in department and cross-functional initiatives.
- Serve as an SME for audits/inspections.
- 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.
- Manage unscheduled reports and smaller Therapeutic Areas.
- Supervise contractors, if applicable.
- Act as a backup when Director SAS TAL is unavailable.
- Oversee team member deliverables as needed.
- Support Health Authority interactions on safety and risk management.
**Decision-making and problem-solving**:
The primary decision-making responsibility involves leadership, safety data analysis and interpretation, pharmacovigilance regulations, and company procedures. The AD SAS operates independently, recognizes potential safety issues, thinks strategically about data interpretation, understands adverse drug reactions, and collaborates effectively. This role requires flexibility, attention to detail, efficiency in handling a significant workload, and completing safety evaluations efficiently.
This position reports to the Director, SAS Therapeutic Area Lead and collaborates closely with various groups, including Global Safety Strategy & Risk Management, Medical Affairs, Global Regulatory Affairs, Clinical, Compliance, Standards and Analytics, Epidemiology, International Pharmacovigilance, Regulatory Medical Writing, vendors, and business partners. Specific roles may include Global Regulatory Leader, Compound Development Team Leader, TASH, Clinical Leader/Development Head, Medical Safety Surveillance and Insight Physicians and Staff, Scientists, Data Analytics/GMS Support Desk Staff.
**Qualifications**:
**Qualifications and Experience**:
- 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
- Flexibility for 3 days per week in-office at our High Wycombe site
**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 and interpret and present complex data for benefit-risk assessment.
- Fluent English
- Excel in a team-based environment with communication and leadership skills.
- Manage deadlines and multiple priorities efficiently.
- Independently influence, negotiate, and communicate with internal and external customers.
**Who We Are**:
We offer a competitive salary and extensive benefits package. The health and well-being of our empl
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