Johnson & Johnson Careers

DRUG SAFETY ASSOCIATE

Horsham, Pennsylvania; Raritan, New Jersey; High Wycombe, United Kingdom
Drug & Product Safety Operations


Job Description

Requisition ID: 5977190926

Janssen Research & Development, LLC, a member of the J&J Family of Companies, is recruiting for a Drug Safety Associate to work in Horsham, PA or Raritan, NJ or High Wycombe, England.

 

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.

 

The Drug Safety Associate will: 

 

Case processing: completion of full case information on the database, including quality review to ensure accuracy and completeness

  • Triage of incoming cases to prioritize for daily workflow management
  • Completion of remaining case data entry (including narrative or auto-narrative), manual coding, label and approval
  • Preparation of SUA summary: Analysis of Similar Events
  • Perform quality review of ICSR which includes review of source documents and ensuring that the case is accurate and that corrections to the case, if applicable, are incorporated.
  • Liaison with Case Receipt and/or Safety Surveillance Physicians (SSP) staff as appropriate to clarify appropriate information required for case processing
  • Other activities relating to case processing as appropriate per case, including but not limited to:
 
  • Single case unblinding, Serious Adverse Event (SAE) /Adverse Event (AE) reconciliation, deviation memo preparation, deletion/admin edit requests, review protocol update request forms for accuracy
  • Completion of all assigned training on company and GMSO procedural documents relating to case processing
  • Completion of training relating to relevant PV Agreements for assigned products
  • Participate in designated activities to support revision/creation of case processing procedural documents
  • Participation in local or global project teams, including on-time delivery of assigned responsibilities
 


Qualifications
Qualifications
 
  • Registered Nurse or Pharmacist (Certification/licensure is required e.g. RN, RPh, PharmD) Or Health/Biomedical Degree (BS, PhD or other related scientific degree/qualification) required
  • Licensed Practical Nurse with bachelor’s degree, or with knowledge of pharmacovigilance usually exhibited by a minimum of 2 years’ experience in pharmaceutical safety-related role required
  • Pharmaceutical industry experience is preferred, with a focus on pharmaceutical safety related areas
  • Case processing experience is desired
  • Knowledge and experience with safety reporting and regulatory compliance, and experience of international safety reporting/regulations are preferred
  • Understanding of medical terminology and ability to summarize medical information
  • Ability to follow guidelines and procedural documents (experience of working with SOPs etc preferred)
  • Oriented to quality, attention to detail and accuracy
  • Manages own work: 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
  • Proactive approach/uses own initiative appropriately
  • Decision-making and problem-solving skills
  • Flexibility and adaptability
  • Positive attitude
  • Good verbal and written communication skills
  • Good computer skills (Word, email) and familiarity with safety systems
  • Knowledge or experience with Excel, PowerPoint, Visio preferred
 


Primary Location
United States-Pennsylvania-Horsham-200 Tournament Drive
Other Locations
North America-United States-New Jersey-Raritan, Europe/Middle East/Africa-United Kingdom-England-High Wycombe
Organization
Janssen Research & Development, LLC (6084)
Job Function
Drug & Product Safety Operations
Requisition ID
5977190926