Post-Doctoral Scientist Fellow, Pharmacovigilance Evaluation and Reporting
At Johnson & Johnson, we use technology and the power of teamwork to discover new ways to prevent and overcome the world’s the most significant healthcare challenges. Our Corporate, Consumer Health, Medical Devices, and Pharmaceutical teams leverage data, real-world insights, and creative minds to make life-changing healthcare products and medicines. We're disrupting outdated healthcare ecosystems and infusing them with transformative ideas to help people thrive throughout every stage of their lives. With a reach of more than a billion people every day, there’s no limit to the impact you can make here. Are you ready to reimagine healthcare?
Here, your career breakthroughs will change the future of health, in all the best ways. And you’ll change, too. You’ll be inspired, and you’ll inspire people across the world to change how they care for themselves and those they love. Amplify your impact. Join us!
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.
POSITION COMPONENTS
ENSURE TIMELY, QUALITY DELIVERABLES FOR ASSIGNED TASKS RELATED TO CORE DELIVERABLES WITH PRECEPTOR OVERSIGHT AS APPROPRIATE (65%)
TRAININGS/MEETINGS/ROTATIONS/PRESENTATIONS (20%)
FELLOWSHIP INITIATIVES (15%)
DECISION-MAKING AND PROBLEM-SOLVING
WORKING RELATIONSHIPS/INTERFACES:
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.
EDUCATION & EXPERIENCE REQUIREMENTS:
REQUIRED SKILLS:
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.
Push the boundaries of science to transform health—and your career.
Join us and advance life-changing treatments for people who need them most. At Johnson & Johnson, our focus is on improving global health equity and developing MedTech and pharmaceutical innovations that impact the future of health. Using AI and robotics to transform surgery or helping data scientists and clinicians formulate new ways to diagnose and treat disease, this work may sound like sci-fi, but it’s all science, all real, and could be your career. Whatever your background, skills, or career goals, there’s a place for you to help solve some of the world’s most pressing health challenges with us.
Accelerate your career while changing the world.
Each of our broadly-based family of companies offers an inclusive and empowering culture and employee benefits (like paid time off to volunteer, transgender-inclusive and same-sex partner health insurance coverage, and more) designed to help you live your best life, however you define it. And our best-in-class learning and development approaches, mentorship, and access to innovators across the world will help you grow your skills and reach your career goals. Because when you're at your best, nothing stands between you and your next breakthrough.