Clinical Operations Specialist

11 hours ago

San Fernando, Central Luzon, Philippines beBeeOperations Full time ₱2,500,000 - ₱5,000,000

At our organization, we are seeking a skilled professional to fill the role of Clinical Operations Specialist. The ideal candidate will have experience in pharmacovigilance and a strong understanding of regulatory requirements related to drug safety.

Responsibilities:
  • We are looking for a detail-oriented individual to manage data entry of vigilance cases in relevant databases according to conventions.
  • The selected candidate will perform quality control of vigilance cases and other documents associated with safety reports.
  • A medical review of vigilance cases according to relevant conventions and regulatory requirements is also part of the job.
  • The candidate will be responsible for follow-up requests of vigilance cases by phone/mail.
  • Pre-analysis of complex cases before data entry is also required.
  • Identification of submission requirements for safety cases is another key responsibility.
  • The candidate will also be responsible for identification of requirements in terms of preparation of ICSR/MLM filters.
  • A review and analysis of ICSRs downloaded from competent authorities databases is also part of the job.
  • Performing reconciliations (partners, medical information, quality complaints) is another key responsibility.
  • The candidate will participate in the operational implementation of new projects.
  • Key contact for projects with support of the team leader/activity manager/project manager is also required.
  • The candidate will be responsible for performing medical review of post marketing cases as assigned.
  • To be the operations lead for assigned post marketing clients is another key responsibility.
  • Drafting/updating of technical agreements/safety management plan/client template is also part of the job.
  • The candidate will be responsible for drafting/updating of SOPs/WPDs/trainings others documents directly related to their activity.
  • Participation in the implementation/maintenance/improvement of processes is another key responsibility.
Requirements:
  • A pharmacist or life sciences degree with more than 3 years experience in PV is required.
  • Previous experience working to deadlines is essential.
  • Client communications skills are also required.
  • Minimum 3 years experience working for service providers performing QC of cases is essential.
  • A pharmaceutical background – strong understanding of GVP, GCP, FDA and regulatory requirements related to drug safety is required.
  • Deep knowledge of pharmacovigilance principles, adverse event reporting, causality assessment is essential.
What We Offer:

We offer a competitive package that includes a salary, benefits, and opportunities for growth and development.

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