OPERATIONS SCIENTIST

Johnson & Johnson Family of Companies - High Wycombe4.2

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

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 with processing 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 and provision of requested data
Assistance in preparation or implementation of corrective/preventative actions relating 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 scientific degree/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 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 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, Europe/Middle East/Africa-United Kingdom-England-High Wycombe
Organization
Janssen Research & Development, LLC. (6084)
Job Function
Drug & Product Safety Operations
Requisition ID
00001EVA