
1001 - 5000 employees
đŒ Consulting
đ„ Healthcare
đ Pharmaceuticals
đ° GROWTH EQUITY VC on 2024-04
Consulting âą Healthcare âą Pharmaceuticals
ProductLife Group is a global lifeâsciences 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.
đ October 22
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.

1001 - 5000 employees
đŒ Consulting
đ„ Healthcare
đ Pharmaceuticals
đ° GROWTH EQUITY VC on 2024-04
Consulting âą Healthcare âą Pharmaceuticals
ProductLife Group is a global lifeâsciences 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.
âą Perform quality control of vigilance cases âą Conduct medical evaluation of reports and files âą Enter vigilance case data into ad hoc databases or other client-agreed formats âą Request case follow-up by phone and email âą Pre-analyze complex cases before data entry âą Evaluate coding, causality, expected/listed status, seriousness, and submission requirements âą Validate documents produced by Data Managers, Vigilance Associates, and documentalists âą Close vigilance files âą Identify requirements and applicable changes for ICSR/MLM filters âą Analyze inclusion and exclusion of EV/MHRA cases âą Perform quality control for clinical and post-marketing cases âą Act as key contact for specific customers with support from an Activity Manager or Line Manager
âą Doctor in Pharmacy/ Pharmacist by training âą Minimum 3 years of experience in a similar position âą Previous experience working to deadlines âą Database experience âą Clinical and Post Marketing case processing experience âą Pharmaceutical background with strong understanding of GVP, GCP, FDA and regulatory requirements related to drug safety âą Deep knowledge of pharmacovigilance principles, adverse event reporting, and causality assessment âą Knowledge of current regulations âą Process-oriented âą Rigorous and able to work in a team âą Microsoft Office proficiency âą Ability to multitask âą Flexibility âą Excellent communication skills
âą Career growth opportunities âą Opportunity to make a meaningful impact on global healthcare âą Purpose-driven work âą Collaboration with a global, innovative team
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