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Associate Director, Signal Detection Analytics Physician Job

Company Name:
Janssen Research & Development, LLC. (60
Raritan, NJ, US
Associate Director, Signal Detection Analytics Physician
Description
Janssen Research & Development (JRD), a member of the Johnson & Johnson Family of Companies, is recruiting for a Associate Director, Signal Detection and Analytics Physician located in Horsham, PA, Titusville, NJ, or Raritan, NJ.
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? disease, epilepsy, migraine prevention and treatment), pain management, and women? 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 /
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The objective of this position is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall Pharmacovigilance process; this includes aggregate signal detection activities for selected products. This includes the development of signal detection strategy. In addition, this position will also support oversight of vendors.
The Associate Director, Signal Detection and Analytics Physician (Associate Director, SDAP) has primary responsibility for determining the medical and scientific relevance of adverse event reports within the context of the product? safety profile as well as other products within the same therapeutic area. These responsibilities include spontaneous reports, clinical and non-clinical studies, literature reports and other sources of safety data.
SDAPs are responsible for the medical assessment of case level and aggregate safety data for new safety concerns and trends and the communication of these issues to the Medical Safety Officer (MSO) and the Safety Management Team. Additionally, SDAPs participate in matrix management activities (Safety Management Team core member) and providing pharmacovigilance expertise on individual case reports and signal detection methods. SDAPs support SMT activities such as evaluating safety issues, preparation of aggregate safety reports such as PBRERs, ad-hoc regulatory reports, Risk Management Plans, and interpretation of surveillance and product quality data. Additionally, SDAPs provide medical expertise in activities such as managing products or project teams, participating on cross-functional teams such as SOP committees, taskforces, work streams and representing GMSO positions, processes and guidances to external business partners.
Qualifications
A Medical degree from a recognized institution is required
Board Certified/Board Eligible/equivalent OR 2 years post-graduate training OR combination of 5 years of post-graduate training in a recognized medical specialty plus clinical medical experience is required
An unrestricted medical license or equivalent or eligibility in one of the territories of GMS operations (US, UK, Singapore) is required
Familiarity with pharmaceutical industry principles of drug development and pharmacovigilance is preferred
Sound knowledge of general medicine and clinical practice, and the ability to assess the clinical relevance of medical data and to interpret its clinical meaning is required
Good communication skills (written and verbal) and the ability to work in a team-oriented, matrix environment are required
Significant experience and judgment required to identify and evaluate issues likely to be relevant in understanding safety profiles of a large product portfolio is required
Aggregate signal detection and reporting experience is preferred
Knowledge in the use of statistical techniques used in single case and signal detection as well as experience applying these technologies is preferred
This position is located in Horsham, PA, Spring House, PA, Titusville, NJ, or Raritan, NJ. and up to 10% domestic and international travel.
BE VITAL in your career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
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Primary Location:
North America-United States-New Jersey-Raritan
Other Locations:
North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Horsham
Organization:
Janssen Research & Development, LLC. (6084)
Job Function:
Drug & Product Safety Science
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Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
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