Pharmaceutical Safety Specialist

3 days ago

Calamba, Calabarzon, Philippines beBeeCase Full time ₱800,000 - ₱1,200,000

Our organization is seeking a skilled professional to fill the position of Case Specialist.

Responsibilities:
  • The selected candidate will be responsible for data entry of vigilance cases in relevant databases according to established conventions and guidelines.
  • Quality control of vigilance cases and associated documents will also be a key responsibility, ensuring accuracy and adherence to regulatory requirements.
  • The individual will conduct medical reviews of vigilance cases, applying relevant conventions and regulatory standards.
  • Additional duties will include following up on vigilance cases via phone or mail, as well as performing pre-analysis of complex cases before data entry.
  • Identification of submission requirements for safety cases and preparation of ICSR/MLM filters will also be an important aspect of this role.
  • The Case Specialist will review and analyze ICSRs downloaded from competent authorities databases, ensuring compliance with regulatory requirements.
  • Reconciliation tasks, such as partner information, medical details, and quality complaints, will be carried out as part of this position.
  • Participation in operational implementation of new projects and serving as a key contact for projects will also be expected.
  • This role will involve conducting medical reviews of post-marketing cases as assigned.
Education and Experience
  • A degree in pharmacy or life sciences, combined with over three years of experience in pharmacovigilance, is required for this position.
Requirements
  • Ability to work under deadlines and maintain effective client communication.
  • Previous experience working for service providers performing quality control of cases.
  • Strong understanding of GVP, GCP, FDA, and regulatory requirements related to drug safety.
  • Deep knowledge of pharmacovigilance principles, adverse event reporting, and causality assessment.

This is an exciting opportunity for a dedicated professional looking to join our team and contribute their skills and expertise.

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