Associate Director, Safety Analysis Scientist

7 months ago

High Wycombe, United Kingdom Johnson & Johnson Full time

The Associate Director (AD) Safety Analysis Scientist (SAS) provides scientific expertise and leads the safety assessment of assigned products. The AD 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 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 deliverables as required.

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).

The AD SAS will function with a high level of independence, with mínimal guidance from the Director, Safety Analysis Scientist (SAS) Therapeutic Area Lead (TAL), be able to link discussions to content, and consistently deliver high quality results with mínimal guidance. The AD SAS will quickly build alliances and be able to independently influence other safety partners to shape strong decisions/outcomes.

**PRINCIPAL RESPONSIBILITIES**:

- 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 mínimal comments from stakeholders and mínimal 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

**DECISION-MAKING AND PROBLEM-SOLVING**:
**REPORTING RELATIONSHIPS**:
This position reports into the Director, Safety Analysis Scientist Therapeutic Area Lead.

**WORKING RELATIONSHIPS/INTERFACES**:
This position works closely with many groups including Global Safety Strategy & Risk Management (GSSRM), Medical Affairs, Global Regulatory Affairs, Clinical, Compliance, Standards and Analytics, Epidemiology, International Pharmacovigilance, Regulatory Medical Writing, the vendor, 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 and Scientists, Data Analytics/GMS Support Desk Staff.

**Qualifications**:
**EDUCATION & EXPERIENCE REQUIREMENTS**:

- 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

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