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
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.
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
- 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
- Develop and update controlled
- 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.
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.
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
- Knowledge in safety reporting
and regulatory compliance, and knowledge of international safety
- Practiced developing,
generating, and reviewing
- 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
- 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
Johnson & Johnson International (Singapore) Pte. Ltd. - ROHQJob Function
Drug & Product Safety OperationsRequisition ID