Drug Safety Associate, Case Processing-9865141017
Description
Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Drug Safety Associate Case Processing, located in Horsham, PA.
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 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 Drug Safety Associate is responsible for the case processing of adverse event reports following company standard operating procedures, internal business practices and regulatory guidance documents, to ensure compliance with worldwide safety regulations and corporate policies.
The Drug Safety Associate will be tasked with the completion of full case information on the database, including quality review to ensure accuracy and completeness. This includes: triage of incoming cases to prioritize for daily workflow management, confirmation of case registration/committal information by Case Receipt staff or other designee, completion of remaining case processing, including labeling and narrative writing as appropriate, liaison with Case Receipt and/or Pharmacovigilance Physician staff as appropriate to clarify appropriate information required for case processing, and other activities relating to case processing as appropriate per case, including by not limited to: single case unblinding, SAE/AE reconciliation, deviation memo preparation, deletion/admin edit requests, review protocol update request forms for accuracy.
The position will be responsible for having an awareness of and input to company procedures and guidance. This includes: completion of all assigned training on company and GMS procedural documents relating to case processing completion of training relating to relevant PV Agreements for assigned products, and participation in designated activities to support revision/creation of case processing procedural documents.
The position will also participate in assigned projects such as inspection/audit readiness activities. Other project work includes: participation in local or global project teams, including on-time delivery of assigned responsibilities, participation in inspections and audits as identified, including interviews and provision of requested data, and other activities/projects related to continuous task or competency based development of personal skills.
Qualifications
Licensed Practical Nurse with at least 5 years experience in safety-related role is required
RN, RPh, PharmD is preferred
Pharmaceutical industry experience is preferred, with a focus on pharmaceutical safety related areas
Case processing experience is preferred
ARISg or Argus or other safety databases experience is preferred
Hospital experience involving clinical cases, medical records is preferred
Understanding of medical terminology and ability to summarize medical information is required
Knowledge and experience with safety reporting and regulatory compliance, and experience of international safety reporting/regulations are preferred
Ability to follow guidelines and procedural documents is required; experience of working with SOPs etc is preferred
Oriented to quality, attention to detail and accuracy
Ability to prioritize, plan and organize work assignments, and able to work under strict timelines
Ability to work both independently and in collaboration with others
Good verbal and written communication skills
Good computer skills (Word, email) and familiarity with safety systems is required
Experience with Excel, PowerPoint, Visio are preferred
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Primary Location:North America-United States-Pennsylvania-Horsham
Organization: Janssen Research & Development, LLC. (6084)
Job Function: Drug & Product Safety Operations
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