Patient Safety and Pharmacovigilance Specialist

🔥 5 hours ago

🌐 Romania, Croatia – Remote

🇷🇴 Romania – Remote 🇭🇷 Croatia – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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WEP Clinical

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2008

💼 Consulting

📦 Logistics

💊 Pharmaceuticals

Consulting • Logistics • Pharmaceuticals

WEP Clinical is a Pharmaceutical Services Provider that specializes in Drug Development Programs, Treatment Access Solutions, and Market Access and Commercialization. The company focuses on providing critical support throughout the entire drug development and commercialization journey, helping sponsors advance their medicines and improve patient access. WEP Clinical offers services such as clinical trial services, expanded access programs, post-approval named patient programs, and market access consulting, ensuring that much-needed therapies reach patients worldwide.

📋 Description

• Execute international adverse event and pharmacovigilance activities in accordance with regulatory agency requirements • Coordinate adverse event and pharmacovigilance activities for sites worldwide • Provide support, training, and oversight for drug safety activities, including product quality complaints and medical information activities • Monitor the pharmacovigilance system through monthly performance reports • Prepare and analyze PV metrics, including KPIs, quality incidents, CAPAs, audits, and inspection outcomes • Compile and trend compliance data; conduct root cause assessments, gap analyses, and corrective-action effectiveness evaluations • Evaluate safety reports and study documents for completeness, accuracy, and clinical relevance • Support audit and inspection readiness and assist with internal audits and health authority inspections • Provide training on adverse event reporting and participate in internal and external meetings • Manage the safety mailbox, assess adverse event reports, and coordinate medical evaluations and escalations • Collaborate with cross-functional teams to enhance PV compliance • Author Safety Monitoring Plans and process adverse events in Argus database • Review and submit safety reports to regulatory agencies, resolve queries, and maintain adverse event logs • Conduct literature reviews for adverse event identification, reconcile AE reports with partners, and manage product complaints • Serve as a PV subject matter expert, support business development, train and oversee staff, and assist with resource onboarding

🎯 Requirements

• Bachelor’s degree in a medical, nursing, pharmaceutical, or life sciences discipline is required • 3+ years’ experience in drug safety / pharmacovigilance in the CRO or pharmaceutical industry • Experience in Clinical Trials and drug development (phases 1-4) • Effective verbal and written communication skills • Working knowledge of Argus Safety Database • Computer literacy and proficiency in Microsoft Office, particularly Word, Excel, and PowerPoint • Familiarity with FDA regulations and ICH guidance • Strong organizational skills and attention to detail • Ability to work effectively in a fast-paced environment and deal effectively with changing priorities

🏖️ Benefits

• Wellness, growth and development initiatives • Team relationship and team event initiatives • Inclusive, supportive work environment • Reasonable accommodation for qualified individuals with known disabilities

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