Manager, Pharmacovigilance Evaluation and Reporting-00000THG
Description
Janssen Research & Development, LLC, a Johnson & Johnson Company, is currently recruiting for a Manager, Pharmacovigilance Evaluation and Reporting - Oncology to be located in Horsham PA, Titusville NJ, Spring House PA, Raritan NJ, or High Wycombe, UK.
Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.
Janssen Pharmaceuticals, Inc., a pharmaceutical company of Johnson & Johnson, provides medicines for an array of health concerns in several therapeutic areas, including: attention deficit hyperactivity disorder (ADHD), cardiovascular disease, general medicine (acid reflux disease, infectious diseases), mental health (bipolar I disorder, schizophrenia), neurologics (Alzheimer’s disease, epilepsy, migraine prevention and treatment), pain management, and women’s health. Our ultimate goal is to help people live healthy lives. We have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market – from patients to practitioners, from clinics to hospitals. For more about Janssen Pharmaceuticals, Inc., one of the Pharmaceutical Companies of Johnson & Johnson, visit http://www.janssenpharmaceuticalsinc.com/
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Manager will be responsible for core safety deliverables including scheduled and ad hoc aggregate reports and will serve as report owner for medium to large and/or complex assigned reports. The Manager will have in-depth product knowledge, serve as product point of contact, and may serve as core Safety Management Team member. Daily activities involve leading strategy development, 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 Manager will partner with team members, stakeholders including MSOs, and a vendor. The Manager will function independently and will have expert knowledge of applicable regulations and guidelines. The Manager will also work closely with Therapeutic Area Lead to support the therapeutic area business.
Qualifications
Bachelor’s Degree in Health, or Biomedical Science, or related area with at least 9 years of pharmaceutical industry or equivalent experience OR an advanced academic degree in Health, Biomedical Science, or related area with at least 6 years of pharmaceutical industry or equivalent experience is required
At least 3 years Clinical/Medical writing or Pharmacovigilance experience is required
Experience analyzing safety information preferred
Periodic Safety Update Report (PSUR) writing experience is strongly preferred
Excellent English verbal and written communication skills required
This position can be located in Horsham PA, Titusville NJ, Spring House PA, Raritan NJ, or High Wycombe, UK
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Primary Location:North America-United States-Pennsylvania-Horsham
Other Locations:North America-United States-Pennsylvania-Spring House, North America-United States-New Jersey-Titusville, Europe/Middle East/Africa-United Kingdom-England-High Wycombe, North America-United States-New Jersey-Raritan
Organization: Janssen Research & Development, LLC. (6084)
Job Function: Drug & Product Safety Science
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