Johnson & Johnson Careers

Program Coordinator

Selangor, Malaysia
Drug & Product Safety Operations


Job Description

Requisition ID: 1805622067W

  • Responsible for all stages of adverse event reporting for clinical study and post-marketing drugs and products.  
  • Accountable for collecting data, investigating facts and circumstances and reporting findings to appropriate stakeholders and regulatory agencies. 
  • Collects, reviews and analyzes data and narratives regarding adverse events, particularly short and long-term effects, involving clinical study or post marketing drugs and products. 
  • Verifies assessments of regulatory reporting requirements are accurate and in accordance with regulatory guidelines and product labeling. 
  • Validates correct codes are assigned to adverse events have been input to appropriate database. 
  • Reviews adverse event files and tracking systems to ensure they are up to date. Examines adverse event reports for accuracy and completeness prior to approval for submission to regulatory agencies. 
  • Interacts with health professionals and consumers to obtain and follow up on reports of possible adverse events. 
  • Verifies accuracy, completeness and validity of information for each report. Reviews and analyzes cumulative safety data for submission to regulatory agencies. Identifies and reports on trends. 
  • Evaluates records concerning potential adverse events which do not meet criteria for entry into database to confirm accurate classification.

Qualifications
Requirements:
  • BS Degree in health-related field or other related scientific field with a minimum of 5 years’ industry experience is required.
  • Minimum of 2 years of pharmacovigilance or clinical experience is preferred.
  • Experience supporting investigations, Non-Conformances (NC), and CAPA is preferred.
  • Excellent communication skills, both written and verbal.
  • Candidate should have demonstrated impeccable ethics and transparency.
  • Ideal candidate is an excellent communicator and relationship builder who is able to challenge yet at the same time engender trust, be recognized for integrity and putting the needs of the organization/team before ones’ own.

Primary Location
Malaysia-Selangor-
Organization
Johnson & Johnson Sdn. Bhd. (8275)
Job Function
Drug & Product Safety Operations
Requisition ID
1805622067W