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DRUG SAFETY ASSOCIATE

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Job Description


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., 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.

 

The Drug Safety Associate will: 

 
  • 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
  • Prioritization of incoming/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
  • Participation in inspections and audits as identified, including interviews and provision of requested data
  • Personal development: continuous development of personal skills whether task or competency-related.  Activities may include project involvement, technical training, shadowing and/or mentoring others, soft-skill development.
  • Mentoring of other DSAs or staff, as identified

Qualifications

Qualifications:

  • A minimum of a bachelor’s degree in Health/Biomedical or related degree required OR Registered Nurse, Licensed Practical Nurse or Pharmacist with current Certification/licensure is required (e.g. LPN, RN, RPh, PharmD)
  • A minimum of 2 years’ experience in pharmacovigilance preferred
  • Single 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 required
  • Ability to follow guidelines and procedural documents required
  • 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
 
 

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.



Primary Location
United States-Pennsylvania-Horsham-100 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
R&D
Requisition ID
1936200103