Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Manager, Safety Analysis Scientist - Pharmacovigilance Evaluation and Reporting. This position can be located in Horsham, PA; Titusville, NJ or Raritan, NJ. Remote locations within the United States may be considered.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.
The Manager, Safety Analysis Scientist (SAS) will provide scientific expertise and lead the safety assessment of assigned products. This individual, in partnership with the Medical Safety Officer (MSO), will be 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. 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. Assist the MSO with activities related to the SMT and with contributions to key safety and clinical documents.
The Manager, SAS will have in-depth product knowledge, will serve as product point of contact, and will provide mentoring to, and oversight of deliverables prepared by, other team members as needed (for complex reports). Function independently, or with moderate guidance from the Therapeutic Area Lead (TAL), be able to link discussions to content, and deliver quality results with minimal guidance. 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 minimal-to-moderate comments from stakeholders and minimal-to-moderate revisions required.
Provide support to Associate Director, SAS for novel projects without defined processes.
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 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.
Contribute to cross-functional training of relevant stakeholders.
Mentor other SASs on activities within the role.
Participate in department and/or cross-functional initiatives and explore innovative ways of presenting data, preparing reports, and improving efficiencies.
Assist in the creation, review and implementation of controlled documents and other related tools.
A minimum of a Bachelor’s degree is required, preferably in Biomedical Science or Healthcare related discipline. An Advanced degree (Master’s PhD) in Biomedical Science or Healthcare related discipline is preferred.
A minimum of 9 years of related industry experience with a Bachelor’s degree or a minimum of 6 years of related industry experience with an advanced degree is required.
- Medical writing or Pharmacovigilance (PV) experience is required.
- Clinical experience is preferred.
- Experience in the Oncology Therapeutic Area is preferred.
Experience with CAR-T (Cell and Gene Therapy) is preferred.
- Working knowledge of medical concepts required.
Knowledge of safety activities in drug development and post marketing, and global safety health authority requirements required.
Experience analyzing complex medical-scientific data from a broad range of sources required.
Experience interpreting and presenting complex data to determine benefit-risk impact is required.
Proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook) is required.
- Must have excellent verbal and written communication skills.
- Must have proven leadership skills.
Must have the ability to plan work to meet deadlines and effectively handle multiple priorities.
The ability to influence, negotiate and communicate with both internal and external customers is required.
The ability to effectively interact with stakeholders, including business partners, across a matrix environment is required.
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.
North America-United States-New Jersey-Raritan, North America-United States-New Jersey-Titusville
Janssen Research & Development, LLC (6084)