Case Specialist (Philippines)

Group 10

ProductLife Group is looking for Case Specialist (Pharmacovigilance) to join and contribute to the activities of the hub. Responsibilities:

Responsible for the Quality control of vigilance cases
Medical evaluation of reports
Data entry of vigilance cases in ad hoc databases or in other formats agreed with the client
Follow-up request of vigilance cases by phone/mail
Pre-analysis of complex cases prior to data entry

Medical evaluation of files on:

• Coding (according to applicable dictionary)
• Causal relationship between the effects and the intake of suspect products (according to applicable method)
• The expected/listed or unlisted nature of the events/effects/incidents
• The seriousness of the events/effects/incidents and the case

Identification of submission requirements for each case Validation of certain documents produced by the Data Manager/ Vigilance Associate / documentalist (phone call forms, etc) Closing of vigilance files Identification of requirements and applicable changes to set up ICSR/MLM filters Analysis of inclusion / exclusion of EV/MHRA cases
To perform QC for clinical/post-marketing cases
Key Contact for specific customers (with the support of an Activity Manager or the Line Manager) Education & Experience:

• Doctor in Pharmacy/ Pharmacist by training
• Minimum 3 years of experience in a similar position
• Previous experience working to deadlines
• Database experience
• Clinical and Post Marketing case processing experience
• 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.

Skills:

• Database experience preferred
• Knowledge of current regulations
• Process oriented
• Rigorous and ability to work in a team
• Use of Microsoft Office tools
• Ability to multitask
• Flexibility
• Excellent communication skills