Case Specialist Philippines 2

Make a meaningful impact on global healthcare — and grow your career while doing it. At ProductLife Group, you’ll join an innovative, forward‑thinking team operating across the world to shape the future of life sciences through expertise, collaboration, and purpose‑driven work.

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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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Ready to take the next step? Apply today and join a global, innovative team that’s shaping the future of life sciences and empowering people to make a real impact in healthcare.

Izvor: https://www.linkedin.com/jobs/view/4482827653/

Nivo: senior