Johnson & Johnson

Title: Drug & Product Safety Specialist

Location: Horsham, PA

Duration: 10 months

Benefits on offer for this contract position: Health Insurance, Life insurance, 401K and Voluntary Benefits

Please note that this is a contract role providing services to Johnson & Johnson through external staffing partners of Kelly OCG. If you are selected for this role, you will be employed by a contract staffing supplier and will not be an employee of Johnson & Johnson

Summary:

Review ICSRs within Global Safety Reporting (GSR) scope of responsibility for reportability based on Standard Operating Procedures

(SOPs), Work Instructions and internal guidance documents.

Responsibilities:

• Responsible for daily manual or electronic submission of ICSRs to RAs and BPs.
• Make submit no submit decisions.
• Record, track and monitor successful transmission in OST. Produce CIOMS Medwatch and fax email, distribute, and upload to document storage
• Monitor transmissions electronic case failure monitoring and (if appropriate) resolution
• Liaise with Support Desk and or Case Processing personnel Performs duties as per the rota such as daily weekly checks and report reviews.
• Monitors GSR mailboxes daily, archive and assign emails for action as needed
• Perform other functional duties associated with Global Safety Reporting as assigned by a senior member of the team.
• Triaging and prioritization of ICSRs for regulatory reporting by following the business rules and SOPs.
• Perform review submissions review and no submit review.
• Performs distribution rule creation update of rules for Global Safety Reporting, and other departments Identifies and resolves issues or prepares for escalation up to more senior member of staff.
• Perform reconciliation
• Participate in User Acceptance Testing (UAT) for upgrade enhancements to safety systems including support of script writing.
• Prepares agendas, facilitates team meetings and takes minutes.
• May take lead on key projects under supervision eg. bi annual review.
• Supports impact assessments under supervision.
• Supports investigation, documentation and track compliance related data under supervision.
• Provides input for:
• Process system improvement
• Global Safety Reporting initiatives such as regulation changes
• Compliance and quality metrics preparation for Global Safety Reporting
• Controlled document creation update
• Quality Investigations and CAPA activities
• Provides support for holiday cover according to the Business Continuity Plan
• Provides training and mentoring to staff as requested.

Qualifications:

• Working knowledge of safety database systems, local case reporting, queries
• Basic understanding of regulatory reporting obligations
• Attention to detail
• Sense of urgency
• Ability to recognize when and what to escalate
• Organizational skills
• Problem solving abilities
• Proficiency with Microsoft (Excel, Outlook etc.) is preferred