Johnson & Johnson Careers

Clinician, Product Safety and Performance

Manila, Philippines
Drug & Product Safety Science


Job Description

Requisition ID: 1805681426W

Position Summary

The Clinician is responsible for activities related to product safety surveillance and risk management including review of data from spontaneous complaints and other sources for accuracy, completeness, regulatory reporting and potential safety issues. Reviews and prepares reports on aggregate data and provides recommendation for further escalation. The clinician prepares complaint trend analysis, product risk assessments including Health Hazard Evaluations, post market safety surveillance reports, risk management reports and FMEAs. Assists in benchmarking best practices with world class organizations, interfaces with notified body, and/or other regulators, and provides input to establish metrics.

This individual will collaborate closely with the Medical/Regional Safety Officers (MSO) and the Quality Units for Post Market Surveillance (PMS) activities and the implementation of medical safety processes within each companies quality system. Additionally, he/she will partner with R&D and Medical Affairs Team to implement medical review and input through the product life-cycle.

This individual will have the responsibility of supervising a team of local health care professionals who will be responsible for activities related to product safety and risk management for assigned operating companies within Johnson & Johnson.

The Clinician has relevant medical background and product/ medical device industry experience.

Qualifications
Basic Qualifications:
  • A Doctor of Medicine, (MD), Doctor of Osteopathy (DO) designation or equivalent, such as MBChB is required with specialty in Infectious Disease.
  • At least 5 years of experience in the pharmaceutical, medical device industry or direct device clinical experience.
  • Regulatory Affairs/ Quality Assurance or complaint handling experience in pharmaceuticals or medical devices preferred
  • Understanding of risk assessment principles preferred
  • Experience interacting with the FDA and/or other regulatory agencies preferred
  • Excellent communications and analytical skills
  • Working knowledge of Microsoft Office, Excel, Power Point, Access

Other Skills & Abilities:
  • Ability to travel as needed or requested is required.
  • Ability to handle complex long-term focused projects involving multiple disciplines or operating companies required.
  • Demonstrated strong writing, planning and organizational skills; ability to prioritize.
  • Flexibility and initiative, as well as the ability to work independently and in a team setting.

Primary Location
Philippines-National Capital-Manila-
Organization
Johnson & Johnson (Philippines) Inc. (8385)
Job Function
Drug & Product Safety Science
Requisition ID
1805681426W