
1001 - 5000 employees
đź Consulting
đĽ Healthcare
đ Pharmaceuticals
đ° GROWTH EQUITY VC on 2024-04
Consulting ⢠Healthcare ⢠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 6 days ago
Where this job comes from
Posted on ProductLife Group's careers page, not through a job board
First seen by Remote Rocketship 6 days ago

1001 - 5000 employees
đź Consulting
đĽ Healthcare
đ Pharmaceuticals
đ° GROWTH EQUITY VC on 2024-04
Consulting ⢠Healthcare ⢠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.
⢠Manage shared and client-specific mailboxes ⢠Register vigilance cases in internal tracking systems ⢠Perform duplicate searches in safety databases ⢠Conduct initial triage and data entry of vigilance cases ⢠Code medical information using MedDRA ⢠Prepare and update case narratives ⢠Ensure patient data anonymization when required ⢠Support follow-up requests and case closure activities ⢠Assess case seriousness and submission requirements ⢠Submit cases to Competent Authorities, Ethics Committees, Partners, and Affiliates as applicable ⢠Generate reports and listings from safety databases ⢠Perform database searches and data extractions ⢠Support KPI calculations and activity monitoring ⢠Prepare weekly, monthly, quarterly, and annual activity reports ⢠Contribute to reconciliation activities and database quality checks ⢠Support EudraVigilance activities, including ICSR downloads and submissions ⢠Perform XEVMPD updates and submissions ⢠Support MHRA, FDA, and other Health Authority reporting activities where required ⢠Participate in the implementation of new client projects ⢠Contribute to process optimization initiatives ⢠Draft and update work instructions, technical agreements, and operational procedures ⢠Support audits and inspections when needed ⢠Maintain compliance with applicable pharmacovigilance regulations and company procedures
⢠Bachelor's degree in Life Sciences, Pharmacy, Nursing, Dentistry, or a related scientific field ⢠Experience in Pharmacovigilance, Drug Safety, Case Processing, Regulatory Affairs, or Database Management is an advantage ⢠Knowledge of pharmacovigilance regulations and safety databases is preferred ⢠Pharmacovigilance case processing ⢠MedDRA coding ⢠EudraVigilance knowledge ⢠Database management and data entry ⢠Microsoft Office Suite ⢠Reporting and KPI monitoring ⢠Regulatory compliance awareness ⢠Strong attention to detail ⢠Excellent organizational skills ⢠Critical thinking and analytical mindset ⢠Effective communication skills ⢠Team-oriented approach ⢠Ability to manage multiple priorities and deadlines
⢠Opportunity to work in an international Life Sciences environment ⢠Exposure to global pharmacovigilance and regulatory activities ⢠Professional development and career growth opportunities ⢠Collaborative and dynamic working environment ⢠Remote work arrangement
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