We are a global pharmaceutical company seeking for dedicated, driven individuals who are eager to contribute to ensuring the alignment of company processes. Here at Johnson and Johnson, we provide equal opportunities for individuals with diverse backgrounds relevant to the role. We nurture a culture of caring in the company, achieving to create a healthy work-life balance for our employees. We believe in putting the needs and well-being of the people we serve first.

Have you always had the ability to make sense of statistical data?

The role seeks individuals with the capability of turning data into information, and converting these into insights relevant for company process. Attention to detail, and capability of managing meaningful collaboration with our partners is needed.

Position Summary:

You will be responsible for generating Pharmacovigilance (PV) compliance metrics for Individual Case Safety Report (ICSR) Health Authority compliance, Aggregate Report Health Authority compliance, case receipt compliance, partner exchange compliance, and vendor specific compliance in support of Global Medical Organization (GMO) and Office of Consumer Medical Safety (OCMS) and performing quality control of standard and ad-hoc metrics and presentations. Supports audits and inspections globally, as subject matter expert for generation of compliance metrics.

You will perform User Acceptance Testing for compliance metrics reports and participate in cross-functional projects passionate about process improvement and innovation.

Principal Responsibilities:

  • Majority of the tasks entail the generation and quality control of metrics related to PV compliance as well as other key GMO/OCMS compliance metrics.
  • Collaborate with internal and external partners and stakeholders to ensure metrics are reported and/or reconciled in a timely manner. Call out non-compliance to management
  • Oversee report and meeting schedules
  • Develop and update controlled documents.
  • Perform User Acceptance Testing for compliance metrics reports.
  • Other duties as assigned.

Decision-making and problem-solving:

You will be accountable for prioritizing and ensuring deliverables are completed on time and are accurate and consistent, follow documented procedures for metrics generation, and consult with your supervisor and mentor for complex issues and changes to processes and procedures.

Independent critical thinkers would thrive in this position as the post entails resolving routine issues and questions without assistance. Raises issues to your Metrics Operations Manager when they cannot be resolved or when timelines are in jeopardy.

Working Relationship/Interfaces

The Metrics Analyst works within a matrix and positive working environment:

You will work closely and collaborate with the Metrics Operations Manager to develop reports to measure compliance.

You will also be interfacing directly with all functions impacting GMO / OCMS monitored compliance metrics (including, but not limited to): PV Operations, Vendor Quality and Compliance Points of Contact, PAC, IPV / LSO, LOC, QPPV, Third Party Compliance Contacts and GRA.
Qualifications

Are you the one we are looking for?

You should be a committed and thorough individual with the following education and experience requirements:

  • Minimum of Bachelor’s Degree in relevant discipline (Science, Medical, Operations, etc.) with 2 years of pharmaceutical industry experience
  • Experience in pharmacovigilance case processing and/or PV compliance monitoring preferred
  • Knowledge in safety reporting and regulatory compliance, and knowledge of international safety reporting/regulations
  • Practiced developing, generating, and  reviewing compliance metrics
  • Understanding of GxP requirements and user acceptance testing

You should possess the following characteristics and abilities:

  • Expertise in Microsoft Excel and Microsoft PowerPoint
  • Adaptable and capable of functioning in a global matrix environment.
  • Excellent written and verbal skills.
  • Charismatic, and ability to influence without authority
  • Experience in developing and conducting presentations for different levels of management; ability to tailor presentations to the appropriate level of detail.
  • Capacity to prioritize tasks and manage time during high-volumes of work
  • Ability to conform, and work in diverse cultural backgrounds

 


Primary Location
Philippines-National Capital-Manila
Organization
Johnson & Johnson International (Singapore) Pte. Ltd. - ROHQ
Job Function
Drug & Product Safety Operations
Requisition ID
1700205905W
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Confirmed 19 hours ago. Posted 30+ days ago.

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