Case Specialist

🕒 October 22

đŸ‡”đŸ‡­ Philippines – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

Where this job comes from

Posted on ProductLife Group's careers page, not through a job board

First seen by Remote Rocketship October 22

Still open on ProductLife Group's site. Checked 17 minutes ago.

Logo of ProductLife Group

ProductLife Group

1001 - 5000 employees

đŸ’Œ Consulting

đŸ„ Healthcare

💊 Pharmaceuticals

💰 GROWTH EQUITY VC on 2024-04

Consulting ‱ Healthcare ‱ Pharmaceuticals

ProductLife Group is a global life‑sciences consulting and outsourcing firm that pairs deep human expertise with intelligent automation to help bring therapies and health products from development to patient access. The company provides end-to-end solutions across product development (pre-clinical to approval), regulatory affairs, CMC & quality, clinical development, engineering and facility construction, market & patient access, safety and compliance, and digital & AI-enabled innovation. ProductLife Group serves biopharma, medtech and consumer health clients, operates a global network of offices covering 150+ countries, and highlights ~1,750 experts and ~10k+ submissions per year.

📋 Description

‱ Perform quality control of vigilance cases ‱ Conduct medical evaluation of reports and files ‱ Enter vigilance case data into ad hoc databases or other client-agreed formats ‱ Request case follow-up by phone and email ‱ Pre-analyze complex cases before data entry ‱ Evaluate coding, causality, expected/listed status, seriousness, and submission requirements ‱ Validate documents produced by Data Managers, Vigilance Associates, and documentalists ‱ Close vigilance files ‱ Identify requirements and applicable changes for ICSR/MLM filters ‱ Analyze inclusion and exclusion of EV/MHRA cases ‱ Perform quality control for clinical and post-marketing cases ‱ Act as key contact for specific customers with support from an Activity Manager or Line Manager

🎯 Requirements

‱ 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 with strong understanding of GVP, GCP, FDA and regulatory requirements related to drug safety ‱ Deep knowledge of pharmacovigilance principles, adverse event reporting, and causality assessment ‱ Knowledge of current regulations ‱ Process-oriented ‱ Rigorous and able to work in a team ‱ Microsoft Office proficiency ‱ Ability to multitask ‱ Flexibility ‱ Excellent communication skills

đŸ–ïž Benefits

‱ Career growth opportunities ‱ Opportunity to make a meaningful impact on global healthcare ‱ Purpose-driven work ‱ Collaboration with a global, innovative team

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