Operations Scientist, Case Processing, Global Medical Safety Operations (1 of 3)
Location:
Horsham , Pennsylvania
Posted:
April 02, 2017
Reference:
6993170123-en-us

Janssen Research & Development, a part of the Johnson & Johnson family of companies, is recruiting for an Operations Scientist, Case Processing, Global Medical Safety Operations to be located in Horsham PA.

 

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found. 

 

Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information. 

 

We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.

 

The Operations Scientist, Case Processing, Global Medical Safety Operations 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.

 

Responsibilities:


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.
  • Liaise with Case Receipt and/or Safety Surveillence Physicans (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

Team leadership: close liaison with Senior DSAs regarding process and workload management, and deputizes for Manager as identified.

  • Takes the lead in team meetings and daily liaison with team members to identify and resolve processing issues
  • Assists Manager with implementation of processes, and issue management
  • Supports and deputizes for Manager as identified.

Supervising product-specific daily workload: prioritization and organization of team workload to maintain regulatory compliance and quality standards

  • Review managers Daily Report(s) to prioritize and ensure compliance with processing timeframes
  • Review regular Edit Check reports to identify processing inconsistencies and errors
  • Monitor Aggregate Reporting Calendars to ensure cases are processed in required timelines

Processes & procedures: awareness of and input to company procedures and guidance

  • 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

Project work: participation in assigned projects, including inspection/audit readiness activities

  • 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
  • Assistance in preparation or implementation of corrective/preventative actions relating to case processing

Mentoring & supervision: Oversight of mentoring of Case Processing (or other identified) staff, and involvement in recruitment and supervision.

  • 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

Process & product expert: act as key contact or point of expertise for team members and external contacts for designated products or processes



Qualifications
  • A degree within the Healthcare profession is required (RN, RPh, PharmD, BS, PhD, or other related scientific degree/qualification).
  • A minimum of 4 years of relevant experience is required
  • Pharmaceutical industry experience with experience in safety related areas is required
  • Case processing experience is required
  • Experience with safety and pharmacovigilance for clinical trials is preferred
  • Knowledge and experience with safety reporting and regulatory compliance, and experience of international safety reporting/regulations is required
  • Experience in team-leadership role is preferred
  • Understanding of medical terminology and ability to summarize medical information is required
  • Ability to follow guidelines and procedural documents (experience of working with SOPs etc.) is required
  • Good verbal and written communication skills
  • Familiarity with safety systems is required
  • Knowledge or experience with Excel, PowerPoint, Visio is preferred


Primary Location
United States-Pennsylvania-Horsham
Organization
Janssen Research & Development, LLC. (6084)
Job Function
Drug & Product Safety Operations
Requisition ID
6993170123

A little about us:
Johnson & Johnson cares for the world - bringing innovative ideas, products and services to advance the health and well-being of people.

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