Drug Safety Associate

Drug Safety Associate

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere.

This role is in support of Cencora's patient and provider support and pharma commercialization services in Canada marketed through our Innomar Strategies business.

Responsibilities:

• Receive, scan and document all pertinent clinical information in compliance with SOP/protocol and applicable legislation
• Work directly with internal and external clients to request additional information or clarification as necessary; Review of source data documents (includes visit report/PIR review) and triaging adverse event information and product, quality complaints as per client needs;
• Data entry and submission of adverse event information and product quality complaints into program specific databases.
• Sorting and filing of incoming documents.
• Perform quality check on adverse event reports as directed by the work instructions
• Assist with and/or perform source data verification checks
• Screening medical and scientific literature for safety information
• Preparation of Reconciliation (weekly, monthly etc.) reports, transcription translations and redaction activities.
• Preparation and conducting solicited follow-up letters and data clarifications.
• Assist and participate in the non-conformance/CAPA process.
• The Drug Safety Associate will also be assigned other duties and tasks as required from time to time.

Education:

• Minimum college level education required. A diploma or degree with a concentration in Life Sciences is a strong asset.

Work Experience:

• 1-3 years experience in Medical Information, Clinical Research or Drug Safety or equivalent and related experience in pharmacy or pharmaceutical fields.
• Knowledge of Pharmacovigilance industry including up to date knowledge of; pharmacovigilance guidelines of Health Canada, US FDA, EMEA and ICH.
• Adaptability to change and to learn new skills as required
• Experience in the medical and/or pharmaceutical field(s), medical terminology is an asset.
• Bilingual, English/French is an asset.

Skills & Knowledge:

• Strong analytical skills.
• Ability to communicate effectively both orally and in writing.
• Effective interpersonal skills.
• Effective organizational skills; ability to multitask
• Superior, proven attention to detail
• Ability to consistently meet deadlines
• Excellent problem-solving skills; ability to communicate and/or resolve issues effectively and efficiently.
• Computer skills (including knowledge of Microsoft Word, Excel, PowerPoint and other Office Programs)
• Good internet required for remote work.