Job description

Requirements

  • Entry level
  • No Education
  • Salary to negotiate
  • Horsham

Description

Janssen Research & Development, LLC, a member of the J&J Family of Companies, is recruiting for a Drug Safety Associate 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.
 
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
Ensure compliance with worldwide safety regulations and corporate policies
 
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 and provision of requested data
              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
 
 
Expertise in operational activities including case processing (or other functional expertise).
This position reports to Manager, Case Processing, Global Medical Safety Operations
 
 
Qualifications:
 
Registered Nurse or Pharmacist (Certification/licensure is required e.g. RN, RPh, PharmD)
Health/Biomedical Degree (BS, PhD or other related scientific degree/qualification)
Licensed Practical Nurse with Bachelors degree, or with knowledge of pharmacovigilance usually exhibited by minimum 5 years experience in pharmaceutical safety-related role
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
Good verbal and written communication skills
Good computer skills (Word, email) and familiarity with safety systems
Knowledge or experience with Excel, PowerPoint, Visio preferred
Flexibility and adaptability
Positive attitude  
 


Qualifications
Qualifications:
 
Registered Nurse or Pharmacist (Certification/licensure is required e.g. RN, RPh, PharmD)
Health/Biomedical Degree (BS, PhD or other related scientific degree/qualification)
Licensed Practical Nurse with Bachelors degree, or with knowledge of pharmacovigilance usually exhibited by minimum 5 years experience in pharmaceutical safety-related role
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

About the company

If you’re thinking about taking your career to a place where you can be seen for the talent you bring to your work, where you’ll have a chance to be the driver of your own career, and where others share your passion for caring and success, then we invite you to explore Johnson & Johnson. BE VITAL in your career and make a unique mark. Join the approximately 129,000 men and women who work within our companies and touch the lives of more than a billion people around the world every day.

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