PharmD Fellow, Safety Analysis Scientist Full-time NEW

Global Safety Strategy & Risk Management (GSSRM) Pharm.D. Fellow

Johnson & Johnson Innovative Medicine is recruiting for a Global Safety Strategy & Risk Management (GSSRM) Pharm.D. Fellow, located in Horsham, PA.

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.

Qualifications

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).

Requirements

• Letter of Intent and 3 Letters of Recommendation required.

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 and 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, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.