Senior Safety Analysis Scientist

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Product Safety

Job Sub Function:
Product Safety Risk Management

Job Category:
Scientific/Technology

All Job Posting Locations:
Lisbon, Portugal

Job Description:

Essential Job Duties and Responsibilities

The Senior Scientist 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 min...