Pharmacovigilance Associate Ii

6 days ago

Oakville, Canada AmerisourceBergen Full time

- What you will be doing
- PRIMARY DUTIES AND RESPONSIBILITIES:

- Recognize and report Adverse Events using the appropriate forms
- Triaging and assessing cases for seriousness based on ICH definition for SAE/SADR
- Assess expectedness based on the global and local Product Monograph (as applicable)
- Responsible for expediting submission of domestic and foreign cases for products with NOC in Canada (HC)

and in the USA (FDA) as per applicable guidelines
- Responsible for narrative writing for all adverse or other reportable events received alone or in combination

with a product complaint or medical information question.
- Perform case evaluation, including causality, severity and seriousness assessments
- Information Management and Pharmacovigilance: Receive, scan and document all pertinent clinical

information in compliance with SOP/protocol and applicable legislation;
- Address medical information inquiries
- Work directly with internal and external clients to request additional information or clarification as necessary;
- Assist in audit preparation
- Review patient information in database and ensure accurate documentation as per client needs;
- Data entry of event information and pertinent details;
- Literature searches
- Reconciliation of event reports;
- Cases Quality Control
- Prepare aggregate reports, including Periodic Safety Update Reports (PSURs) and Periodic Benefit-Risk

Evaluation Reports (PBRERs)
- Submit ICSR cases to Regulatory Authorities and/or our clients
- Sorting of incoming faxes and documents; and
- Filing of source documentation
- Other tasks assigned by the Manager, as needed.
- May be required to be on standby/ on call as part of this role.

EXPERIENCE AND EDUCATIONAL REQUIREMENTS:

- Bilingual, English/French strongly preferred
- Bachelor’s degree in related discipline or diploma in a life sciences program
- 3-5 years’ experience in Drug Safety, Clinical Research and/or equivalent and related experience in the

pharmaceutical industry;
- Familiarity with Adobe Pro an asset
- Can do attitude, with proven ability to meet strict deadlines
- Knowledge of medical terminology is a strong asset
- Able to work any 8-hour shift between 8:00 AM-8 PM, if necessary

MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:

- Strong knowledge of pharmacovigilance industry including up to date knowledge of; GUI 0102, GVP, ICH

GCP MHRA, Canadian Food and Drugs Act, and US FDA guidelines an asset
- Advanced knowledge of pharmaceutical distribution industry
- Strong business and financial acumen
- Strong analytical and mathematical skills
- Ability to communicate effectively both orally and in writing
- Effective interpersonal and leadership skills
- Effective organizational skills, attention to details
- Ability to consistently meet deadlines
- Excellent problem-solving skills; ability to resolve issues effectively and efficiently
- Excellent presentation skills
- Knowledge of Microsoft Word, Excel, PowerPoint and other Office Programs
What your background should look like
EXPÉRIENCE ET NIVEAU D’ÉDUCATION REQUIS :_
- Bilingue anglais/français nettement préférable
- Baccalauréat dans une discipline connexe ou un diplôme dans un programme de sciences de la vie;
- 3 à 5 ans d’expérience en innocuité des médicaments, recherche clinique et/ou une expérience équivalente et connexe dans l'industrie pharmaceutique;
- Familiarité avec Adobe Pro est un atout
- Une attitude gagnante, avec capacité éprouvée à respecter des échéances strictes
- Connaissance de la terminologie médicale est un atout
- Capable de travailler pendant toute période de 8 heures, comprise entre 08h00-20h00, si nécessaire
- COMPÉTENCES, CONNAISSANCES ET APTITUDES MINIMALES REQUISES :_
- Connaissance solide de l’industrie de la pharmacovigilance, dont connaissance à jour de ; GUI 0102, GVP, ICH GCP MHRA, Loi canadienne sur les aliments et drogues, et directives de la FDA (États-Unis) un atout
- Connaissance approfondie de l'industrie de la distribution pharmaceutique
- Solide sens des affaires et des finances
- Compétences analytiques et mathématiques solides
- Capacité de communiquer efficacement oralement et par écrit
- Compétences interpersonnelles et de leadership efficaces
- Sens de l'organisation; souci du détail
- Capacité à respecter systématiquement les échéances
- Excellentes aptitudes en résolution de problèmes; capacité à résoudre les problèmes de manière efficace et efficiente
- Excellentes aptitudes de présentation
- Connaissance de Microsoft Word, Excel, PowerPoint et autres programmes Office

What AmerisourceBergen offers

We offer competitive total rewards compensation. Our commitment to our associates includes benefit programs that are comprehensive, diverse and designed to meet the various needs across our associate population.

Throughout our global footprint and various business units, we take a balanced approach to the benefits we offer. Many benefits are co

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