Jnj Jobs – Operations Scientist

Job Description:

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.

Job Responsibilities:

  • 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
  • Review workload to prioritize and ensure compliance with processing timeframes
  • Review regular ICSR Data Consistency reports to identify processing inconsistencies and errors
  • Monitor Aggregate Reporting Calendars to ensure cases are processed in required timelines
  • Completion of all assigned training on company and Global Medical Safety Operations (GMSO) procedural documents relating to case processing
  • Completion of training relating to relevant Pharmacovigilance (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
  • Collaborate closely with Global Case Receipt and/or Global Medical Safety Operations Physicians (GMSOP) 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, Serious Adverse Event (SAE)/Adverse Event (AE) reconciliation, deviation memo preparation, deletion requests and approvals, review protocol updates for accuracy
  • Vendor oversight activities for assigned products
  • Operational management activities for onshore teams and vendors, including but not limited to:
  • workload and productivity monitoring activities, workload meetings, vendor meetings, monitoring quality of ICSRs
  • 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 Analysis of Similar Events
  • Perform quality review of Individual Case Safety Reports (ICSR) which includes review of source documents and ensuring that the case is accurate and that corrections to the case, if applicable, are incorporated.

Job Requirements:

  • Ability to optimally delegate work responsibilities to others
  • Ability to follow guidelines and procedural documents (experience of working with SOPs etc. preferred)
  • Registered Nurse or Pharmacist (Certification/licensure is required e.g. RN, RPh, PharmD).
  • Ability to view the “big picture” and understand impact of decision taken within the team or function
  • Oriented to quality, attention to detail and accuracy
  • Experience in pharmaceutical safety related areas. Case processing experience is desired
  • Manages own work: ability to prioritize, plan and coordinate work assignments, and able to work under strict timelines
  • Understanding of medical terminology and ability to summarize medical information
  • Health/Biomedical Degree (BS, PhD or other related scientific degree/qualification)
  • Knowledge and experience with safety reporting and regulatory compliance, and experience of international safety reporting/regulations are preferred
  • Practical knowledge of global regulatory pharmacovigilance requirements
  • Ability to work both independently and in collaboration with other teams
  • Proactive approach/uses own initiative appropriately
  • Licensed Practical Nurse with Bachelor’s degree, or with knowledge of pharmacovigilance usually exhibited by experience in pharmaceutical safety-related role

Job Details:

Company:  Johnson & Johnson

Vacancy Type:  Full Time

Job Location: Edinburgh, Scotland, UK

Application Deadline: N/A

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