Johnson & Johnson Careers
MEDICAL SAFETY SCIENTI
Requisition ID: 9703190315
Johnson & Johnson Consumer Products Company is recruiting for a Medical Safety Scientist to be located in Skillman, NJ.
The Medical Safety Scientist (MSS) is a medical safety expert with in-depth product knowledge of assigned portfolio of Consumer products (this may include OTC monograph drugs, cosmetics and class I and II medical devices).
The Medical Safety Scientist has primary responsibility to support safety surveillance and risk management activities for assigned portfolio of products including planning, conducting meetings, database searching, aggregate safety analysis and case level review, writing, project management/coordination of development of strategic safety documents, and oversight of deliverables produced by other team members. Medical Safety Scientist provides subject matter expertise and technical guidance on functional requirements and is accountable for the quality and technical content of these reports, timelines fulfilment and stakeholders communication.
The MSS works in a cross-functional matrix environment and liaises with Medical Affairs (MAF), Regulatory Affairs (RA), Research & Development (R&D), Toxicology, Quality Assurance (QA), and Legal to ensure accuracy and thoroughness of the evaluations performed for assigned products.
- Analyze safety-associated issues that are or might be due to product quality issues, the analysis of safety surveillance observations, the response to safety inquiries from the Medical Safety Officers and internal/external authorities using Company safety database(s), regulatory agency databases (e.g., FAERS and MAUDE), the medical literature, and exposure information for a wide portfolio of products
- Ensure timely, quality reports/safety analyses related to core deliverables
- Strategy development in collaboration with MSOs/RMSOs and other stakeholders
- Initiate/Conduct/Oversee searches of internal and external databases
- Perform management review of all vendor produced materials (e.g. draft reports and assessment responses); and/or lead aggregate safety analysis and case level revisions
- Participates in cross-functional training of relevant stakeholders
- Performs training, onboarding, and oversight of onsite or offshore resources and is responsible to ensure compliance with SOPs/WIs, global regulations/guidelines
- Trains, self, employee, and contractors on the pharmacovigilance responsibilities prior to work engagements; updates training of self and others as required in compliance with schedules and regulations
- Participate or lead· department and/or cross-functional initiatives
- Contributes to periodic metrics reports and ensures reports’ accuracy and timelines are met
- Bachelors degree in life-sciences or health-care field or advanced degree (e.g., RN, MS, MPH, PharmD, or PhD) required
- A minimum of 3 years of experience in Pharmacovigilance or related industry required
- Proven experience working in matrix environment and cross-functional teams
- In-depth working knowledge of AE safety databases to identify system enhancements and efficiencies preferred
- Comprehensive clinical/medical writing experience highly preferred
- Strong English verbal and written communication skills.
- Advanced-level skills in MS Office (Outlook, Word, PowerPoint, and Excel) is required.
- Provide guidance to other scientists and partners vendors- preferred
- Experience working safety databases including MEDDRA coding preferred
- Experience reviewing literature publications preferred
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
United States-New Jersey-Skillman-199 Grandview Road
J & J Consumer Inc. (6101)
Drug & Product Safety Science