Pharmacovigilance Case Specialist (Hybrid)

Group ProductLife; Philippines; Hybrid; PHP 400,000 - 650,000; Full time

Job summary

ProductLife Group is seeking a Case Specialist (Pharmacovigilance) to join the hub and contribute to quality control, medical evaluation of reports, and data entry of vigilance cases.

The role requires a Doctor of Pharmacy, a minimum of 3 years in a similar position, and solid knowledge of GVP/GCP and regulatory drug safety requirements. Hybrid & flexible working with life sciences clients.

Qualifications

• 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

Responsibilities

• Quality control of vigilance cases and medical evaluation of reports
• Data entry of vigilance cases into ad hoc databases as required
• Follow-up requests of vigilance cases by phone or email
• Pre-analysis of complex cases prior to data entry
• Medical evaluation of files: coding, causality, seriousness, and submission needs
• Close vigilance files and coordinate with Data Manager and clients
• QC for clinical/post-marketing cases and act as key contact for customers

Skills

Database experience

Knowledge of current regulations

Process oriented

Rigorous and team work

Microsoft Office tools

Multitasking

Flexibility

Excellent communication skills

Education

Doctor in Pharmacy/ Pharmacist by training

Job description

ProductLife Group is seeking a Case Specialist (Pharmacovigilance) to join the hub and contribute to quality control, medical evaluation of reports, and data entry of vigilance cases.

The role requires a Doctor of Pharmacy, a minimum of 3 years in a similar position, and solid knowledge of GVP/GCP and regulatory drug safety requirements. Hybrid & flexible working with life sciences clients.