PharmD Fellow Safety Analysis Scientist - Johnson and Johnson
Horsham, PA 19044
About the Job
The GSSRM Pharm.D. Fellowship is a postgraduate training program designed to prepare the Fellow to become proficient at safety analyses and ad hoc report writing.
The Fellow, 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.
Key Responsibilities:
- 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.
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 in July 2025.
- 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).
- Letter of Intent and 3 Letters of Recommendation required.
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