Pharmacovigilance Specialist

Emploi pas sur LinkedIn

🕒 il y a 1 mois

🌐 États-Unis, Brésil, +3 autres pays – Distant

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🌲 North Carolina – Distant

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💵 $50 000 - $99 000 / an

⏰ Temps Plein

🟢 Junior

🦅 Parrain de Visa H1B

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👻 Score fantôme 5%

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🗣️🇺🇸🇬🇧 Anglais requis

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Logo of Worldwide Clinical Trials

Worldwide Clinical Trials

1001 - 5000 employés

🏥 Santé

💼 Conseil

📦 Logistique

Healthcare • Consulting • Logistics

Worldwide Clinical Trials est une organisation mondiale de recherche contractuelle (CRO) qui offre des services complets d'essais cliniques. Ils se spécialisent dans le soutien aux études dans divers domaines thérapeutiques tels que l'oncologie, la cardiologie et les maladies rares. Avec plus de 30 ans d'expérience, Worldwide Clinical Trials met l'accent sur un soutien personnalisé et des solutions sur mesure tout au long du cycle de développement des médicaments. Leurs services incluent la surveillance clinique, la gestion des données, le recrutement de patients et le conseil réglementaire, garantissant précision et attention sur-mesure pour chaque essai clinique.

Description

• Responsible for the collection, processing, evaluation and reporting of incoming Serious Adverse Event (SAE) data according to applicable regulatory guidelines/requirements • Author Safety Management Plan for assigned studies • Review incoming SAE data for completeness and accuracy • Perform data entry in the Safety Database and/or complete applicable tracking of incoming safety information • Generate queries for missing or unclear information and follow-up with sites for resolution • Perform QC of SAEs processed by other PV Associates • Generate regulatory reports and perform safety submissions as needed

🎯 Exigences

• Bachelor's degree in a science-related field, nursing, or equivalent • Minimum of 1 year of pharmacovigilance experience (pre-approval clinical trials) • Equivalent combination of relevant education and experience • Computer literacy and strong working knowledge of MS Office applications (Excel, PowerPoint, Word) • Excellent written and verbal communication skills • Excellent organization skills and attention to detail • Ability to handle multiple competing priorities while adhering to applicable timelines • Ability to work independently, prioritize work effectively and work successfully in matrix team environment • Ability and willingness for potential limited travel (domestic and international) as needed

🏖️ Avantages

• Competitive benefits package depending on location • Pay equity and transparency

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