Safety Analysis Scientist Fellow - 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 jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Product Safety

Job Sub Function:

Product Safety Risk Management

Job Category:

Scientific/Technology

All Job Posting Locations:

Horsham, Pennsylvania, United States of America

Job Description:

We are searching for the best talent for a PharmD Fellow, Safety Analysis Scientist, to be located in Horsham, PA.

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

Purpose: The Global Safety Strategy & Risk Management (GSSRM) PharmD Fellowship is a postgraduate training program designed to prepare the Fellow to become proficient at safety analyses and ad hoc report writing.

The PharmD Fellow, Safety Analysis Scientist, in partnership with the Medical Safety Officer (MSO) and under the mentorship and support from the preceptor, 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 Fellow 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 Fellow will gain a high-level understanding of case processing, safety surveillance, and review of medical literature and clinical trial data.

The Fellow will function under the guidance/support from the preceptor, and other team members, be able to link discussions to content, and deliver quality results with guidance from the preceptor and the team.

You will be responsible for:

• Support 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.
• With mentorship from the preceptor and/or Safety Analysis Scientist (SAS), ensure high quality safety evaluations and reports with moderate comments from stakeholders and moderate revisions required.
• Provide support to SAS for novel projects, to bring value through completion of task-based activities without defined processes.
• Support SMT activities (e.g. preparing and presenting data, compiling meeting minutes, updating signal tracking information).
• Provide support for Health Authority interactions regarding safety and risk management, both written and verbal.
• Provide presentations to internal and external stakeholders including guest lectures at universities, continuing education etc.
• Participate in rotational experience in other safety areas such as case processing, signal management etc.
• Assist in the development, promotion, and recruitment of the GSSRM Fellowship Program.
• Assist in precepting advanced practice pharmacy experience (APPE) pharmacy students.

Qualifications / Requirements:

Education:

• Pharm.D. candidates must have graduated from an ACPE-accredited Doctor of Pharmacy program in the last 2 years or will have received a Pharm.D. degree prior to start of the fellowship.

Experience and Skills:

• Solid understanding of medical concepts.
• Excellent English verbal and written communication skills.
• Ability to understand and analyze complex medical-scientific data from a broad range of sources.
• Ability to interpret and present complex data to determine benefit-risk impact.
• 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 balance multiple priorities.
• Proficiency in Microsoft applications (e.g. Word, Excel, and PowerPoint).

Other:

• Letter of Intent and 3 Letters of Recommendation required.

Ineligibility for severance.

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.

If you are under 18 years of age you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent’s consent for the background check

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Required Skills:

Preferred Skills:

Action-Oriented, Analytical Reasoning, Clinical Operations, Coaching, Compliance Risk, Data Analysis, Data Reporting, Data Savvy, Medicines and Device Development and Regulation, Quality Assurance (QA), Quality Control (QC), Report Writing, Researching, Safety Investigations, Safety-Oriented, Serious Adverse Event Reporting, Technical Writing, Technologically Savvy