Case Specialist

🕒 October 22

🇵🇭 Philippines – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👻 Ghost score 15%

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ProductLife Group

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

💼 Consulting

🏥 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 • Enter vigilance cases into ad hoc databases or other client-agreed formats • Make follow-up requests for vigilance cases by phone and email • Pre-analyze complex cases before data entry • Evaluate coding according to applicable dictionaries • Assess causal relationships between effects and suspect products according to applicable methods • Determine whether events, effects, or incidents are expected/listed or unlisted • Assess seriousness of events, effects, incidents, and cases • Identify submission requirements for each case • Validate documents produced by Data Managers, Vigilance Associates, and documentalists • Close vigilance files • Identify requirements and applicable changes for ICSR/MLM filters • Analyze inclusion/exclusion of EV/MHRA cases • Perform QC for clinical and post-marketing cases • Serve 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 and adverse event reporting • Experience with causality assessment • Knowledge of current regulations • Proficiency with Microsoft Office tools • Ability to multitask • Flexibility • Excellent communication skills • Ability to work in a team • Process-oriented and rigorous approach

🏖️ Benefits

• Career growth opportunities • Opportunity to make a meaningful impact on global healthcare • Collaboration with an innovative, forward-thinking global team • Purpose-driven work • Ability to work remotely

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