Drug Safety Associate

🔥 12 hours ago

🇨🇦 Canada – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

đź‘» Ghost score 10%

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Logo of Cencora

Cencora

10,000+ employees

đź’Ľ Consulting

📦 Logistics

🏥 Healthcare

Consulting • Logistics • Healthcare

Cencora is a company dedicated to improving the health and well-being of both people and animals globally. Built on the legacy of AmerisourceBergen, Cencora offers a wide range of industry-leading solutions that encompass specialty logistics, warehousing, drug research, clinical development support, and more. They provide commercialization and patient access support and offer wholesale and specialty distribution services. Cencora serves a diverse clientele, including pharmaceutical companies, physician practices, pharmacies, and health systems. The company also extends its services to animal health, managing operations and delivering products for animal pharmaceutical care. With a strong global footprint, Cencora aims to reshape healthcare delivery through innovative products and solutions, striving to create healthier futures for all.

đź“‹ Description

• Receive, scan, and document pertinent clinical information in compliance with SOPs, protocols, and applicable legislation • Work with internal and external clients to request additional information or clarification • Review source data documents, including visit report/PIR reviews • Triage adverse event information and product quality complaints according to client needs • Enter and submit adverse event information and product quality complaints into program-specific databases • Sort and file incoming documents • Perform quality checks on adverse event reports according to work instructions • Assist with and/or perform source data verification checks • Screen medical and scientific literature for safety information • Prepare reconciliation reports, transcription translations, and redaction activities • Prepare and conduct solicited follow-up letters and data clarifications • Assist and participate in the non-conformance/CAPA process • Perform other assigned duties and tasks as required

🎯 Requirements

• Minimum college level education required • Diploma or degree with a concentration in Life Sciences is a strong asset • 1–3 years of experience in Medical Information, Clinical Research, Drug Safety, or equivalent related experience in pharmacy or pharmaceutical fields • Knowledge of the pharmacovigilance industry • Up-to-date knowledge of pharmacovigilance guidelines from Health Canada, US FDA, EMEA, and ICH • Adaptability to change and willingness to learn new skills as required • Experience in medical and/or pharmaceutical fields; medical terminology is an asset • Bilingual English/French is an asset • Strong analytical skills • Effective oral and written communication skills • Effective interpersonal skills • Effective organizational skills and ability to multitask • Superior, proven attention to detail • Ability to consistently meet deadlines • Excellent problem-solving skills • Computer skills, including Microsoft Word, Excel, PowerPoint, and other Office programs • Good internet required for remote work

🏖️ Benefits

• Medical, dental, and vision care • Backup dependent care • Adoption assistance • Infertility coverage • Family building support • Behavioral health solutions • Paid parental leave • Paid caregiver leave • Training programs • Professional development resources • Mentorship programs • Employee resource groups • Volunteer activities • Remote work arrangement

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