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Senior Scientist, Pharmacovigilance Evaluation & Reporting
Horsham, Pennsylvania; Raritan, New Jersey
Drug & Product Safety Science
Requisition ID: 0468180511
Janssen Research & Development, LLC, a Johnson & Johnson Company, is currently recruiting for a Senior Scientist, Pharmacovigilance Evaluation and Reporting (PVER), to be located in Horsham, PA or Raritan, NJ.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
The Senior Scientist, PVER will be responsible for core safety deliverables including scheduled and ad hoc aggregate reports and will serve as report owner for assigned reports (medium to large volume, standard complexity). The Sr. Scientist will have in-depth product knowledge and will support Safety Management Team (SMT) deliverables as required. Daily activities involve planning, conducting meetings, database searching, aggregate safety analysis and case level review, writing, project management/coordination of strategic safety documents, and oversight of deliverables produced by other team members. The Sr. Scientist will partner with team members, stakeholders including Medical Safety Officers (MSOs), and a vendor.
- Ensure timely, quality reports/safety analyses related to core deliverables with oversight as appropriate
- Collaborate with Therapeutic Area Safety Head (TASH)/MSO/Safety Surveillance Physician (SSP) and other stakeholders on strategy development
- Initiate/Conduct/Oversee searches of internal and external databases
- Perform and/or lead aggregate safety analysis and case level review
- Author, contribute, and coordinate the preparation of core safety deliverables
- Ensure commitments (e.g., Pharmacovigilance Agreements (PVAs), assessment reports) are met
- Partner with vendor to develop reports/deliverables
- Provide SMT support as needed
- Act as ad hoc member for assigned products as appropriate
- Training/ Meetings/ Audits/ Inspections
- Participate in cross-functional training of relevant stakeholders
- Act as product or process Subject Matter Expert (SME) during audits/inspections
- Department initiative involvement
- Participate or lead department and/or cross-functional initiatives
- A Bachelor’s Degree in Health or Biomedical Science is required with a minimum of 6 years industry experience or equivalent
- Advanced Degree Preferred in Health or Biomedical Science with a minimum of 4 years industry experience or equivalent is preferred
- Experience working in a safety department or pharmacovigilance is required
- Clinical/Medical writing experience is preferred
- Working knowledge of applicable global, regional, and local regulatory requirements (eg, ICH guidelines) is preferred
North America-United States-New Jersey-Raritan
Janssen Research & Development, LLC. (6084)
Drug & Product Safety Science