Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
With $81.6 billion in 2018 sales, Johnson & Johnson is the world's most comprehensive and broadly-based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. There are more than 250 Johnson & Johnson operating companies employing approximately 125,000 people in 60 countries throughout the world.
Calling all big thinkers and world-changers who want to drive their careers forward across more than 250 leading businesses in consumer, pharmaceuticals and medical technology. If you have the talent and desire to touch the world, Johnson & Johnson has the career opportunities to help make it happen.
The Pharmacovigilance Evaluation and Reporting (PVER) Fellowship is a postgraduate training program designed to prepare you to become proficient at safety analyses, and ad hoc report writing, through collaboration with partners to collect, interpret, and assemble data to accurately communicate the benefit-risk of the product.
In this role, in partnership with the Medical Safety Officer (MSO) and under the mentorship of the preceptor, you will be 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.
You will also 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.
You will assist the MSO with activities related to the SMT and with contributions towards key safety and clinical documents.
In addition, you will gain a high-level understanding of case processing, safety surveillance, industry regulations and guidance for scheduled aggregate reports, and review of medical literature and clinical trial data. The Fellow will partner with PVER team members, stakeholders, and a vendor.
Lastly, you will function under the mentorship/support from the preceptor, Therapeutic Area Lead (TAL), and other team members, be able to link discussions to content, and deliver quality results with mentorship from the preceptor and the team.
Ensure timely, quality deliverables for assigned tasks related to core deliverables with preceptor oversight as appropriate (65%)
- Developing knowledge of PV regulations and purpose of scheduled aggregate reports.
- 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 PVER 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 build value through completion of task-based activities without defined processes.
- Review and/or write safety topics for scheduled aggregate reports.
- Provide input and review to key regulatory or clinical documents as appropriate.
- Demonstrate leadership in the SMT and support the MSO.
- Support SMT activities (e.g. preparing and presenting data, compiling meeting minutes, updating signal tracking information).
- Support SAS in proactive safety data reviews, if applicable and form a safety position across GMS which can be leveraged for aggregate safety reports.
- Provide support for Health Authority interactions regarding safety and risk management, both written and verbal.
- Participate in department and/or cross-functional initiatives.
- Provide presentations to internal and external partners including guest lectures at universities, continuing education etc.
- Participate in rotational experience in other GMS areas such as case processing, signal management etc.
- Assist in the development, promotion, and recruitment of the GMS Fellowship Program.
- Assist in mentoring pharmacy students.
Decision-making and problem-solving
- Thorough understanding of safety reports, international pharmacovigilance regulations, and company procedures/processes.
- Recognize potential issues and or safety issues and escalate to preceptor, report owner or line manager.
- Think strategically with respect to data interpretation and an ability to understand nature of adverse drug reactions and complex associations.
- High level of flexibility and ability to (re)prioritize work.
- Data cleaning/QC skills.
- Attention to detail and ability to organize data.
- Ability to work across multiple functions and therapeutic areas.
- Understand stakeholder/customer needs, be able to establish alliances and influence other groups.
- Evaluate and incorporate reviewer comments in draft reports and respond accordingly.
This position works closely with many groups including Global Medical Safety, Medical Affairs, Global Regulatory Affairs, Clinical, Compliance, Standards and Analytics, Epidemiology, International Pharmacovigilance, Regulatory Medical Writing, the vendor, and business partners. Specific roles may include Global Regulatory Leader, Compound Development Team Leader, Therapeutic Area Safety Head, Clinical Leader/Development Head, Medical Safety Surveillance and Insight Physicians and Staff and Scientists, Data Analytics/GMS Support Desk Staff.
- Doctor of Pharmacy degree from an ACPE accredited Doctor of Pharmacy Program.
- Working knowledge of medical concepts.
- Excellent English verbal and written communication skills.
- Ability to understand and analyse 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 around milestones and effectively prioritize multiple tasks.
- Proficiency in Microsoft Word, Excel, and PowerPoint.
- Ability to influence, negotiate and communicate with both internal and external customers.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
North America-United States-New Jersey-Raritan
Janssen Research & Development, LLC (6084)