Case Manager Position

1 day ago

Lipa City, Calabarzon, Philippines beBeePharmaceutical Full time ₱3,000,000 - ₱5,000,000
Pharmaceutical Specialist Role

We are seeking an experienced Pharmaceutical Specialist to join our team. As a key member, you will be responsible for contributing to the activities performed in the hub.

  • Data entry of vigilance cases into relevant databases according to relevant conventions.
  • Quality control of vigilance cases and other documents associated with safety reports.
  • Medical review of vigilance cases according to relevant conventions and regulatory requirements.
  • Following up on vigilance cases by phone or mail.
  • Pre-analysis of complex cases before data entry.
  • Identifying submission requirements for safety cases.
  • Identifying requirements for preparation of ICSR/MLM filters.
  • Reviewing and analyzing ICSRs downloaded from competent authorities databases.
  • Performing reconciliations (partners, medical information, quality complaints).
  • Participating in operational implementation of new projects.
  • Key contact for projects (with support of the team leader/activity manager/project manager).
  • To perform medical review of post-marketing cases as assigned.
  • To act as the operations lead for assigned post-marketing clients.
  • Drafting/updating technical agreements/safety management plans/client templates.
  • Drafting/updating SOPs/WPDs/trainings other documents directly related to their activity.
  • Participating in implementation/maintenance/improvement of processes.
Education and Experience
  • A Pharmacist or Life Sciences degree with more than 3 years experience in PV.
Profile:
  • Previous experience working to deadlines.
  • Client communications.
  • Minimum 3 years experience working for service providers performing QC of cases.
  • Pharmaceutical background - strong understanding of GVP, GCP, FDA and regulatory requirements related to drug safety.
  • Deep knowledge of pharmacovigilance principles, adverse event reporting, causality assessment.

This is a unique opportunity to contribute to the growth and success of our organization. If you have the required skills and qualifications, we encourage you to apply.

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