• J&J Family of Companies
  • $111,680.00 -166,760.00/year*
  • Raritan , NJ
  • Scientific Research
  • Full-Time
  • 2 John F Goellner Dr


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Janssen Research & Development,
LLC, a member of the Johnson & Johnson Family of Companies, is recruiting
for a Operations Scientist located in Horsham, PA or Raritan, NJ.















The Operations Scientist
is responsible for the case processing of adverse events reports following
company standard operating procedures, internal business practices and
regulatory guidance documents, to ensure compliance worldwide safety
regulations and corporate policies.











The Operations Scientist
will:













+ Responsible for 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



+ Liaise 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 & end-of-study unblinding, SAE/AE reconciliation, deviation memo
preparation, deletion/admin edit requests and approvals, review protocol update
request forms for accuracy



+ Review managers Daily Report(s) to prioritize and ensure compliance withprocessing timeframes



+ Review regular Edit Check reports to identify processing inconsistencies and error



+ Monitor Aggregate Reporting Calendars to ensure cases
are processed in required timelines



+ 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



+ Promotion of awareness of procedural document
requirements within team



+ Participation in local or global project teams,
including on-time delivery of assigned responsibilities



+ Participation in inspections and audits as identified, including interviews andprovision of requested data



+ Assistance in preparation or implementation of corrective/preventative actionsrelating to case
processing



+ Regular meetings with mentors
in Case Processing, and completion of mentoring checklists/documents



+ Provision of the on-the-job training and mentoring of DSA staff



+ Participates in candidate interviews and may assist
in on boarding of new hires



+ Supervision of contractor DSAs as identified



+ Act as key contact or point of
expertise for team members and external contacts for designated products
or processes








Qualifications



Qualification:













+ Registered Nurse
or Pharmacist (Certification/licensure is required e.g. RN, RPh, PharmD)



+ Health/Biomedical Degree (BS, PhD or other related scientificdegree/qualification)



+ Licensed Practical Nurse
with Bachelor's degree, OR with knowledge of
pharmacovigilance usually exhibited by minimum 6 years' experience in
pharmaceutical safety-related role



+ Six or more
years of pharmaceutical industry experience is required, with experience
in 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



+ Strong leadership skills,
ability to lead a team



+ Ability to view the \"big picture\" and understand impact
of decision taken within the team or function



+ Practical knowledge of global regulatory pharmacovigilance requirements



+ Understanding of medical
terminology and ability to summarize medical information



+ Ability to follow guidelines and procedural documents (experience of workingwith 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 effectively delegate work responsibilities to others



+ 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

Organization

Janssen Research & Development, LLC. (6084)

Job Function

Drug & Product Safety Operations

Requisition ID

848#######
Associated topics: aseptic, aseptic technique, clinical, drug development, immuno oncology, medical, nutritionist, pharmacology, trauma, vaccine

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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