Case Specialist Philippines 1

Group ProductLife; Philippines; Hybrid; PHP 600,000 - 900,000; Full time

Job summary

Group ProductLife is seeking a Case Specialist (Pharmacovigilance) in the Philippines to join the hub and support client projects. The role focuses on quality control, medical assessment of reports, data entry, and proactive case follow-up by phone or email.

The ideal candidate has a pharmacy degree, at least 3 years in a similar role, and experience with pharmacovigilance concepts, regulatory requirements, and database handling. Hybrid and flexible working arrangements are available.

Qualifications

• Doctor of Pharmacy or registered Pharmacist.
• 3+ years in a similar role with deadlines.
• Experience with vigilance databases and data entry.
• Understanding of GVP, GCP, FDA requirements for drug safety.

Responsibilities

• Quality control of vigilance cases.
• Medical evaluation of reports.
• Data entry in ad hoc databases.
• Follow-up requests by phone or mail.
• Pre-analysis of complex cases prior to data entry.
• Code events per dictionaries and assess causality.
• Validate documents produced by data managers.
• Close vigilance files and update case status.
• Identify ICSR/MLM filter changes as needed.
• QC for clinical/post-marketing cases.
• Serve as key contact for customers with support from manager.

Skills

Database experience

Regulations knowledge

Process oriented

Rigorous teamwork

MS Office

Multitasking

Flexibility

Communication skills

Education

Doctor of Pharmacy

Tools

Databases

Regulatory knowledge tools

Job description

Job Description

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

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