Job title: Pharmacovigilance associate (novotech)

Roles and Responsibilities

• Responsibilities:

  • Preparation of a safety management plan, preparing safety DB configuration documents for each project; preparing slides for project kick off meetings.

  • Case processing activities and drafting safety narratives, monitoring of safety mailbox, filing study documents in TMF.

  • Manage unblinding procedures.

  • Conduct literature searches and monitor for adverse event reports as well as monitor post approval commitments.

  • Participate in clinical study reconciliation activities, as requested by the client.

  • Liaise with medical monitors/drug safety physicians, clients, and study teams as appropriate to clarify information required for case processing.

  • Participation in inspection/audit related activities; Assistance in preparation or implementation of corrective/preventative actions relating to case processing.

  • Timely submission of reports to regulatory agencies in accordance with applicable regulations and tracking the details of submissions for compliance.

  • Provision of on-the-job training and mentoring of junior staff.

• Experience and Qualifications:

  • Registered nurse/pharmacist or with health/biomedical degree or other related scientific degree/qualification is required.

  • 2 years to 4 years of pharmaceutical/CRO experience with focus on safety related areas in clinical trial is required.

  • Experience in coding medical terminologies, case processing, safety report submission is preferred.

  • Thorough knowledge of medical terminology and ability to summarise medical information is required.

  • Strong computer proficiency and ability to work in specific databases is required/preferred.

  • Ability to follow guidelines and procedural documents is required. Experience of working with SOPs etc. is required.

  • Fluent in both written and oral English.

  • Good interpersonal skills to professionally communicate with all levels of the organizations.

  • Good time management & multi-tasking capability.