Senior Pharmacovigilance Safety Scientist, Benefit Risk

🔥 3 minutes ago

🌐 Germany, Croatia, +3 more countries – Remote

🇩🇪 Germany – Remote 🇭🇷 Croatia – Remote 🇬🇧 United Kingdom – Remote 🇲🇰 North Macedonia – Remote 🇳🇱 Netherlands – Remote

⏰ Full Time

🟠 Senior

🎲 Risk

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ProPharma

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 2001

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

💰 $8.6M Venture Round on 2020-10

Healthcare • Logistics • Manufacturing

ProPharma is a leading research consulting organization in the life sciences industry. The company specializes in providing custom solutions across the full product lifecycle, from early discovery to post-market monitoring. ProPharma's services include regulatory sciences, clinical research solutions, quality and compliance services, pharmacovigilance, medical information, and R&D technology. Known for its deep domain expertise, ProPharma assists clients in the pharmaceuticals, biotechnology, and medical device sectors with regulatory support, clinical development, and quality management. ProPharma's global team supports a wide range of therapeutic areas including oncology, cardiovascular, and rare diseases, among others, ensuring effective and efficient delivery of life-saving therapies.

📋 Description

• Author and quality review aggregate reports, including PSURs/PBRERs, PADERs/Annual Reports, ACO, and DSURs, for submission to Health Authorities • Author and review Risk Management Plans (RMPs) • Author and quality review Signal Management Reports • Perform literature searches and validity checks for aggregate reports • Manage and reconcile relevant process trackers • Serve as subject matter expert and train and mentor individuals • Extract and validate data, including RSI, sales, previous reports, RMPs, and signals • Generate Line Listings from the safety database and quality check them when required • Provide reliable support for high-priority ad-hoc activities • Perform literature validity checks and duplicate searches in the relevant tool • Participate in internal and external audits and inspections as an SME when required • Interact with client personnel to resolve issues related to assigned activities • Ensure client deliverables comply with relevant regulatory requirements and agreed timelines • Independently plan and execute tasks such as aggregate report preparation • Liaise with directors and management and coordinate work performed by PV Scientists • Lead by example and uphold company quality standards

🎯 Requirements

• 5+ years’ experience in Pharmacovigilance, focused on Risk Management Plans • Bachelor/Master's Degree in Pharmacy, Nursing, Life Science, or another health-related field, or equivalent qualification/work experience • Experience presenting metrics and leading internal and client quality discussions • Experience in literature screening activities and/or authoring and reviewing aggregate reports • Experience authoring and updating Risk Management Plans • Significant knowledge of signal detection methodologies • Experience managing CCDSs • Knowledge of regulatory safety variation processes

🏖️ Benefits

• Remote working support • Hybrid working encouraged for new hires near an office • Diversity, equity, and inclusion commitment • Safe and empowering workplace • Applications personally reviewed by recruitment team • Applicants receive an outcome on their application