Case Expert

2 days ago

Cavite City, Calabarzon, Philippines beBeePharmacovigilance Full time ₱2,000,000 - ₱3,500,000
Pharmacovigilance Specialist Job

This position is for a highly skilled Pharmacovigilance Specialist to join our dynamic team. As a specialist, you will be responsible for various tasks related to pharmacovigilance.

Responsibilities:
  • Data Entry: You will enter data of vigilance cases into relevant databases according to established conventions.
  • Quality Control: Quality control of vigilance cases and associated safety reports will be your responsibility.
  • Medical Review: Medical review of vigilance cases based on conventions and regulatory requirements will be performed by you.
  • Follow-up: Follow-up requests for vigilance cases via phone or mail will be handled by you.
  • Pre-analysis: Pre-analysis of complex cases before data entry will also be part of your responsibilities.
  • Submission Requirements: Identification of submission requirements for safety cases will be required from you.
  • ICSR/MLM Filters: Requirements for preparation of ICSR/MLM filters will also be part of your job.
  • Review and Analysis: Review and analysis of ICSRs downloaded from authorities' databases will be performed by you.
  • Reconciliations: Performing reconciliations (partners, medical information, quality complaints) will also be part of your responsibilities.
  • New Projects: Participation in operational implementation of new projects will be expected from you.
  • Key Contact: You will be the key contact for projects with support from the team leader/activity manager/project manager.
  • Post-marketing Cases: Perform medical reviews of post-marketing cases assigned.
  • Lead Operations: Lead operations for assigned post-marketing clients.
  • Technical Agreements: Draft technical agreements/safety management plans/client templates.
  • Draft SOPs/WPDs/Trainings: Draft SOPs/WPDs/trainings and other documents related to the activity.
  • Process Implementation: Participate in process implementation/maintenance/improvement.
Education and Experience:
  • A Pharmacist or Life Sciences degree with more than 3 years experience in Pharmacovigilance is required.
Profile:
  • Prior experience working under deadlines is essential.
  • Client communications are crucial for this role.
  • A minimum of 3 years experience in service providers performing QC of cases is necessary.
  • A strong understanding of GVP, GCP, FDA, and regulatory requirements related to drug safety is required.
  • An in-depth knowledge of pharmacovigilance principles, adverse event reporting, causality assessment is also required.

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