PharmD 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 Med Tech, 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.

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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.

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.

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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.

• 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…