PharmD Fellow, Safety Analysis Scientist
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Job Location:
Horsham, PA - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at
Job Function:
Product SafetyJob Sub Function:
Product Safety Risk ManagementJob Category:
Scientific/TechnologyAll Job Posting Locations:
Horsham Pennsylvania United States of AmericaJob Description:
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 products 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:
- CV 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 () or contact AskGS to be directed to your accommodation resource.
Key Skills
- Teacher Coaching
- Public Health
- Google Docs
- Classroom Experience
- Systems Engineering
- Research Experience
- Teaching
- Grant Writing
- Leadership Experience
- Mentoring
- Public Speaking
- Writing Skills
About Company
Johnson & Johnson Ajman About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Toda ... View more
