Senior Pharmacovigilance Safety Scientist, Benefit Risk

🔥 0 minutes ago

🌐 Serbia, Philippines, +3 more countries – Remote

🇷🇸 Serbia – Remote 🇵🇭 Philippines – Remote 🇭🇷 Croatia – Remote 🇲🇰 North Macedonia – Remote 🇧🇦 Bosnia and Herzegovina – 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 as part of Pharmacovigilance activities • Author and quality review Signal Management Reports • Perform literature searches and validity checks for aggregate reports • Manage and reconcile relevant process trackers • Act 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 support for high-priority ad-hoc activities • Perform literature validity checks and duplicate searches using the relevant tool • Participate in internal and external audits or inspections as SME when required • Interact with client personnel to resolve issues related to assigned activities • Ensure client deliverables comply with regulatory requirements and agreed timelines • Independently plan and execute tasks such as aggregate report preparation • Perform other duties as assigned

🎯 Requirements

• Bachelor’s/Master's Degree in Pharmacy, Nursing, Life Science, or another health-related field, or equivalent qualification/work experience • 4+ years’ experience in Pharmacovigilance with a focus on Risk Management Plans • 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 and knowledge of regulatory safety variation processes • Ability to liaise with directors, management, PV Scientists, clients, and Health Authorities • Ability to coordinate work and uphold quality standards

🏖️ Benefits

• Remote working supported • Hybrid working encouraged for new hires within a reasonably short commute of an office, as agreed with the manager • Equal Opportunity Employer commitment • Diversity, equity, and inclusion commitment • Safe and empowering workplace • Recruitment applications personally reviewed by a member of the recruitment team • Applicants receive an outcome to their application